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Pre-Filled Syringes and Injectable Drug Devices
9 January - 11 January 2024
Pre-Filled Syringes and Injectable Drug Devices

Conference Overview

Kick off 2024 and set the tone for the year at SAE Media Group's 16th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will return to London in January to unite leaders from the industry, bringing you the latest advances in the combination product drug delivery space and the chance to collaborate across a 3 day programme.

As part of SAE’s leading Injectable Drug Delivery Series, the 3-day event will comprise of a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference comprising of morning keynote plenaries and parallel afternoon topic streams as detailed below addressing the industry’s hottest topics:

  • Device Innovations for Large Volume and Highly Viscous Drug Delivery
  • Sustainability by Design and Material Selection
  • Primary Packaging Development
  • Digital Integration for Connected Devices

This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in January 2024!

FEATURED SPEAKERS

Abha Raveau Violette

Abha Raveau Violette

Associate Director, Devices and Digital Therapeutics, AstraZeneca
Alex Russell

Alex Russell

Digital Health Partnerships, Takeda
Alexander Prisacar

Alexander Prisacar

Scientific Expert for Devices, Boehringer Ingelheim
Ali Matour

Ali Matour

Principal Device Engineer, GSK
Alphons  Fakler

Alphons Fakler

Director Human Factors Engineering/User Experience, Novartis
Anna Sawicki

Anna Sawicki

Combination Product Design Control Lead, Pfizer R&D UK Limited
Annie Zavadil

Annie Zavadil

Device Project Leader, Novartis
Bo Kowalczyk

Bo Kowalczyk

Chief Commercial Officer, ApiJect
Cecile Gross

Cecile Gross

Category Manager Parenteral, Nemera
Cedric Gysel

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson
Charles  Potter

Charles Potter

Technical Project Leader, Chiesi Ltd
Chris Muenzer

Chris Muenzer

Vice President Innovation and Development, Haselmeier
Cinzia Rotella

Cinzia Rotella

Project Leader, Sanofi
Claus Geiger

Claus Geiger

Global Medical Device Project Leader, Sanofi
Claus-Juergen Maier

Claus-Juergen Maier

Circular Economy and Waste Lead, Sanofi
Courtney Soulsby

Courtney Soulsby

Global Director, Healthcare, BSI Group
Cristiana Heese

Cristiana Heese

P&L Development, Boehringer Ingelheim
Daanish Ahmed Khan

Daanish Ahmed Khan

Director, Novo Nordisk A/S
David Harrison

David Harrison

Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl
Elise Legendre

Elise Legendre

Head of Primary Container & Safety System Development, Sanofi
Fatima Bennai-Sanfourche

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
George Moore-Arthur

George Moore-Arthur

Senior Global Regulatory Professional, Novo Nordisk
Hans Jensen

Hans Jensen

Business Development Leader, Cambridge Design Partnership
Heinrich Martens

Heinrich Martens

Vice President Regulatory Affairs, Fresenius Kabi
Jacopo Michieli

Jacopo Michieli

Sr. Device Engineer, CSL Behring AG
Joel Richard

Joel Richard

Chief Development Officer, Enterome
John Merhige

John Merhige

CEO, Credence MedSystems
Julian Dixon

Julian Dixon

Senior Director, AstraZeneca
Kyle Berman

Kyle Berman

Principle Engineer, Pfizer Ltd
Louisa Harvey

Louisa Harvey

Founder and Principal, Harvey Medical
Louise Place

Louise Place

Director, GSK
Mark Hassett

Mark Hassett

Vice President of Business Development, Credence MedSystems
Matthew Jones

Matthew Jones

Senior Medical Sector Manager, DCA Design International
Montse Jansa

Montse Jansa

General Manager & Managing Director Denmark, Merck A/S
Nicola Coles

Nicola Coles

Sustainability Director, BioPhorum
Niels Otterstrom Jensen

Niels Otterstrom Jensen

Head of TakeBack Program, Novo Nordisk
Pascal Lagorgette

Pascal Lagorgette

Head of Product Development, Gerresheimer
Peter Harley

Peter Harley

Head of Technology, Crux Product Design Ltd
Richard Crowther

Richard Crowther

Snr Manager Regulatory Affairs, Amgen
Sanjay Kumar Rout

Sanjay Kumar Rout

Senior Manager, Device development and Technology Transfer of Medical Device Drug Device Combination Product, Biocon Biologics Ltd
Sean McPike

Sean McPike

Global Product Stewardship Lead, Eli Lilly
Steve Hoare

Steve Hoare

Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)
Steven Malbon

Steven Malbon

Combination & Physical Devices Manager, Medical Engineering Technologies Ltd
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Thomas Wejs Moeller

Thomas Wejs Moeller

Director Global Regulatory Affairs - Device, Novo Nordisk
Tina Arien

Tina Arien

Associate Director, Janssen Pharmaceutica
Ulrich Stahl

Ulrich Stahl

Director New Technology, Harro Hofliger

Abha Raveau Violette

Associate Director, Devices and Digital Therapeutics, AstraZeneca
Abha Raveau Violette

Abha Raveau-Violette has a Masters in Mechanical Engineering from the State University of New York with over 14 years of experience in Combination Products and Medical Devices in Europe and the US.

She has developed, launched, and managed complex endovascular devices and combination products with a wide range of applications. These include prefilled syringes, autoinjectors, stents and stent delivery systems.

Her personal motto is the quote from Maya Angelou, ‘People will forget what you said, people will forget what you did but people will never forget how you made them feel’ and she brings this to life by helping improve patients’ lives by solving complex device problems.
 

Alex Russell

Digital Health Partnerships, Takeda
Alex Russell

Alex Russell is a Digital Health professional with 10+ years experience in Pharmaceutical industry partnerships, Corporate venture capital, and Startup business development. He is passionate about Emerging technologies and Business model innovation to Transform healthcare.

Alexander Prisacar

Scientific Expert for Devices, Boehringer Ingelheim
Alexander Prisacar

Alexander Prisacar is a Scientific Expert for Devices within Boehringer Ingelheim’s Device Technology unit. As a skilled Medical Device engineer, Alexander has experience in the development and lifecycle management of Combination Products in the pharmaceutical industry. He supported the successful launch of Cyltezo®, the first and only FDA-approved interchangeable biosimilar to Humira®.


Alexander has a master’s degree in Mechanical Engineering and Industrial Management from the University of Sheffield. Additionally, he completed the university course “Devices and Combination Products” from the University of Maryland Baltimore County.


With his work at Boehringer Ingelheim, he likes to ensure regulatory compliance to attain a product that is safe for patients to use.
 

Ali Matour

Principal Device Engineer, GSK
Ali Matour

Ali Matour is a highly skilled med tech professional with a solid foundation in Biomedical Engineering. His background spans from research and development to successful product launches. Before joining GSK, Ali worked on the development of Software as a Medical Device (SaMD). Presently, his expertise has transitioned into combination products. In his role as a Device Workstream Lead, Ali has delivered numerous device projects to launch.

Alphons Fakler

Director Human Factors Engineering/User Experience, Novartis
Alphons  Fakler

Alphons Fakler leads the Human Factors Engineering team at Novartis’ Global Packaging and Device Development and is located in Basel, Switzerland.
Alphons spent the last 20 years of his career in medical device and pharma packaging development. He has worked on many drug delivery device activities like development of subcutaneous and intravitreal PFS, autoinjectors and digital health solutions. Previous areas of responsibility span a wide range from implementing and validating high volume manufacturing lines and parenteral packaging development to medical device risk management, Software as Medical Device (SaMD) and external partner management.
Alphons holds a State Examination Degree in Pharmaceutical Sciences from Ludwig-Maximilian-University Munich.

 

Anna Sawicki

Combination Product Design Control Lead, Pfizer R&D UK Limited
Anna Sawicki

Anna Sawicki leads the Pfizer Prefilled Syringe Combination Product Development team in Pfizer’s Drug Product Design and Development organization. She has over 25 years of industry experience in large and small molecule manufacturing and device development and manufacturing, the last 11 years have been spent in combination product development. Her current focus is on developing efficiencies across the drug and device development to shorten development timelines. Anna holds a Bachelor of Science in Chemical Engineering from Illinois Institute of Technology and Bachelor of Science in Chemistry from DePaul University.

Annie Zavadil

Device Project Leader, Novartis
Annie Zavadil

Bo Kowalczyk

Chief Commercial Officer, ApiJect
Bo Kowalczyk

Bo Kowalczyk, the Chief Commercial Officer at ApiJect, boasts nearly three decades of experience in the pharmaceutical and medical device industries. Prior to his current role, he served as Vice President of Sales, North America, at Syngene International, aligning operational expertise with prospecting efforts to optimize client satisfaction. As President at Eurofins Bioanalytical Services, Bo oversaw division strategy, P&L, M&A support, corporate partnerships, and daily operations for large molecule Bioanalysis. As Global Vice President at Eurofins Bioanalytical Services, he integrated services and supported global business development in BioPharma Services. He also held the position of Vice President, Business Development and Marketing at AIT Bioscience, achieving sales and profitability growth by establishing a network of preclinical toxicology service providers. His professional journey and extensive industry knowledge demonstrates his dedication to providing safe and effective medicines to patients in all markets.

Cecile Gross

Category Manager Parenteral, Nemera
Cecile Gross

Cécile Gross is Marketing Global Category Manager at Nemera, focusing on Parenteral Devices. She oversees the product portfolio strategy, development and life-cycle for safety system, pen injector and on-body injector platforms. She has an experience of more than two decades in the Medical Device Industry, marketing BtoB technological products and implementing product lifecycle management for various kinds of devices. Graduated in International Business, she completed her initial training with a master’s degree in Marketing and Management in the Healthcare Industry at IMIS Institute, Lyon France.

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson
Cedric Gysel

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

 

Charles Potter

Technical Project Leader, Chiesi Ltd
Charles  Potter

Charles has more than 30 years experience in the drug delivery industry. He has been employed for the last four years as part of the device development team at Chiesi, an Italian family owned pharmaceutical company with a turnover of ~€3bn. Chiesi is a leader in respiratory medicines and has an expanding range of rare disease products which utilize a range of delivery technologies.

However, most of Charles’ career has focused on novel injectable technologies. Following an engineering degree, Charles joined PowderJect Pharmaceuticals and saw it grow from 4 to >1,000 employees. He then founded and was CEO of Glide Pharma for 12 years before working as an independent consultant with a portfolio of companies which were either developing a proprietary drug delivery technology or were selecting a delivery technology for their novel compound.
 

Chris Muenzer

Vice President Innovation and Development, Haselmeier
Chris Muenzer

Chris Muenzer is the Vice-President of Innovation and Development at Haselmeier. He leads a team of experts that create customized drug delivery systems for pharmaceutical and biotechnology companies. He has over 18 years of experience in the pharmaceutical and medical device industry, having worked at Novartis, Roche and the Battelle Memorial Institute. During this time, he has worked at all stages of device development from initial concept, engineering development, clinical trials and launch. Mr Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh (PA, US). He is also the inventor of several patents and is a frequent contributor to industry conferences and ISO standards.

Cinzia Rotella

Project Leader, Sanofi
Cinzia Rotella

Cinzia holds a degree in Materials Science and a PhD in Polymer physics from the KULeuven University. She has joined Sanofi in 2016 as a Sr. Materials Scientist and she is now Project Leader for Life Cycle Management activities in the Medical Device Unit.

Claus Geiger

Global Medical Device Project Leader, Sanofi
Claus Geiger

Education:
Pharmacist, PhD, MBA (Henley Business School), Qualified Person according to EU Regulations and holder of various expert qualifications.
 

Professional Experience:
Worked for top ten global pharma companies Roche and Sanofi. He has held various roles in the field of injectable drug delivery systems for biotherapeutics with expanding responsibilities: QA/QC, Manufacturing, Supply Chain, Key Account Management of device partner companies, Global Medical Device Surveillance, Global Device Project Leader and Drug Device Integrator.
 

Special interests:
Drug Device Integration during the R&D and Industrialization phases of novel biotherapeutics, Drug Device combinations with connectivity, sustainability, establishing and working with cross-functional diverse teams.
 

Claus-Juergen Maier

Circular Economy and Waste Lead, Sanofi
Claus-Juergen Maier

Claus-Jürgen Maier is an Environmental Expert, leading waste and circular economy for industrial waste and products end of life at Sanofi. He has more than 17 years of experience within the field of health, safety, and environment (HSE) at Sanofi and Infraserv Höchst within local and global positions. This includes the role as Emergency Manager Campus Höchst, HSE team lead R&D Frankfurt, HSE business partner for the biologics platform and most recently as eco-design project lead for Sanofi. Claus-Jürgen holds a master and a PhD in Chemistry, both from the University of Heidelberg.

Courtney Soulsby

Global Director, Healthcare, BSI Group
Courtney Soulsby

Courtney Soulsby works as a Global Director for the Healthcare and Life Sciences sector team for BSI (British Standards Institution), focusing on healthcare sustainability. Courtney has worked with pharmaceutical and med tech industries and their supply chain for over ten years – with a deep understanding the issues with regulation, environment, security, compliance, quality, and other risk exposures when manufacturing and transporting healthcare products.

Cristiana Heese

P&L Development, Boehringer Ingelheim
Cristiana Heese

Education: Master Degree in Chemical Engineering from Royal Institute of Technology (KTH) Stockholm, Sweden.


Since 2021, I have held a Packaging Engineer position for Combination Products at Boehringer-Ingelheim within the Manufacturing Science and Technology -Packaging group. Prior joining Boehringer- Ingelheim, I had the opportunity to work for global R&D organizations of Johnson& Johnson, Essity and Freudenberg Group.


As a scientist in R&D organizations, I have gathered a deep experience in product development and innovation of Feminine Hygiene Products, Tissue Products, Personal Protective Equipment, Medical Devices and Packaging for Medical and Combination Products.


I led the development of innovative products with the end-to-end responsibility, doing pre-studies in the front-end area, qualifying products with consumer, coordinating product testing and simulations, but also supporting technical transfer and commercialization from development stage to manufacturing.
 

Daanish Ahmed Khan

Director, Novo Nordisk A/S
Daanish Ahmed Khan

Daanish is a seasoned technology leader with a solid track record from MedTech industry including hearing aids, ostomy care etc. He is currently serving as the Director for Connected Solutions & Integration where he is responsible for the engineering function to bring the connected solutions in various therapeutic areas such as Diabetes, Obesity and Rare Diseases to the market.


Daanish has a M.Sc. in Wireless Communication from University of Aalborg, Denmark and executive certificate in Systems Engineering from MIT Cambridge, U.S.A.
 

David Harrison

Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl
David Harrison

David J Harrison is a business lead, operations head, novelist, and senior director within biopharma and medical devices, although not necessarily in that order. Amongst his sources of inspiration, he lists his wife and family at the very top, not too closely followed by Vonnegut, Murakami, and Bowie.


Over the last twenty-five years, David is delighted to have contributed towards some important medicines, most of which require novel and innovative medical devices, often surrounded by carefully designed eco-systems. He believes in the power of partnerships to create lasting value for patients.


David was the joint recipient of the 2020 PDA Innovation award. His first novel, Recursion, was published in 2021.


You can follow David on LinkedIn (linkedin.com/in/harrisondavid), and Instagram (@davidjharrisonwriter).
 

Elise Legendre

Head of Primary Container & Safety System Development, Sanofi
Elise Legendre

With 20 years of experience across pharma, Elise currently serves as Head of primary container and safety system development in medical device at Sanofi.
Elise is responsible of leading the drug integrated product development for biologics, small molecules an vaccines on prefilled syringe based delivery system. Her group is mainly leading the operation of the PFS development and the transfer of the developed container and safety system to R&D center and manufacturing groups. Before this position, she was supporting various medical devices combination products, such as auto injectors, prefilled syringes projects as PFS expert and project manager.

Prior joining Sanofi, Elise was GSK’s packaging head on an industrial site in Normandy. She was managing the LCM activities on primary, secondary packaging.
Before this, Elise worked in Aseptic and Packaging manufacturing area as operational manager where she served in various roles focused on manufacturing, product commercialization and operational excellence.
 

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
Fatima Bennai-Sanfourche

Dr. Fatima Bennai-Sanfourche is working currently as Global Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.


Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.


She has more than 20 years of experience in the quality management, Regulatory Affairs and development of medical devices and combination products.


She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays.


In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the pharmaceuticals portfolio.
 

She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).


She is also leading the project of the implementation of MDR for PH-Bayer AG.


She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according to the medical Device regulation.


Since July 2021 she is also a member of the European Commission Post-Market Surveillance (PMS) task force responsible for the preparation of the MDR PMS guidance according to the Article 83.


 

George Moore-Arthur

Senior Global Regulatory Professional, Novo Nordisk
George Moore-Arthur

Following an BSc in Biomedical science and MSc in Biotechnology I am currently working at Novo Nordisk as a global regulatory professional responsible for driving regulatory strategy in key global markets for Novo Nordisk digital health & IVD products. Prior to joining Novo Nordisk, I worked for the UK regulatory agency (MHRA) in various roles including medicinal pharmaceutical products and safety & surveillance for a range of medical devices (including surgical, wound management and IVD devices).

Hans Jensen

Business Development Leader, Cambridge Design Partnership
Hans Jensen

Hans is leading the business development efforts for the Drug Delivery sector at Cambridge Design Partnership. He is an experienced industry expert within drug delivery devices and has a broad understanding and hands on experience from early conceptual work to implementing high volume manufacturing lines. Working with major Biopharma customers he has worked with most parenteral delivery systems such as pen injectors, infusion pumps, OBDS devices - including managing a successfully launched FDA cleared connected Auto Injector system.
Hans holds a Bachelor’s degree in Electronics Engineering as well as an executive MBA from Henley Management College.
 

Heinrich Martens

Vice President Regulatory Affairs, Fresenius Kabi
Heinrich Martens

Heinrich Martens, VP Regulatory Affairs, with more than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams. Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role. Beside his work, he spends time and supports social projects. Traveling and time with his family is also important.

Jacopo Michieli

Sr. Device Engineer, CSL Behring AG
Jacopo Michieli

Jacopo Michieli has close to 15 years of experience in development of primary packaging for pharmaceutical use.

Holding various positions in Stevanato group for over 10 years, he has significantly contributed to the design and industrialization of innovative Primary packaging.

He also managed the packaging operations transition of medical device in USA while working at the Innovation Site of Philips in Eindhoven.

In 2019 he joined CSL Behring in Bern as Sr. Device Engineer supporting the introduction of combination products and defining new syringe platforms.

He has a Mechanical Engineering background and a degree on “Economics and Management” from Venice University.
 

Joel Richard

Chief Development Officer, Enterome
Joel Richard

In the past 30 years, Joël has held global leadership positions in various biotech and pharma companies such as Ipsen, Merck Serono and Ethypharm. Most recently Chief Development Officer of MedinCell, he led all the Drug Development operations of the company including clinical, regulatory and quality activities. Previously, Joël was Senior Vice-President, Pharmaceutical Development for peptides & small molecules at Ipsen. A graduate from Ecole Normale Supérieure (Paris-Saclay), Joël holds a PhD in Materials Science/Colloids & Interface Science from Paris 6 University and “Habilitation à Diriger les Recherches” from Bordeaux 1 University.

John Merhige

CEO, Credence MedSystems
John Merhige

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

Julian Dixon

Senior Director, AstraZeneca
Julian Dixon

After 24 years at Team Consulting supporting the development of drug delivery devices, Julian joined AstraZeneca biopharmaceutical development in 2022 to be in one of the key player organizations as the future of combination product human factors is being shaped. Julian’s background is in mechanical engineering and psychology. Both have remained fascinating and provide more than enough fuel for continued curiosity.

Kyle Berman

Principle Engineer, Pfizer Ltd
Kyle Berman

Kyle has a degree in Mechanical Engineering and over 10 years’ experience in design and engineering. His early career focussed on the development of tractors and heavy machinery before moving onto medical devices in 2016.


During his time working for Pfizer’s Devices Centre of Excellence he has been the Technical Lead on a selection of electromechanical device projects. He is involved in suitability assessments, specification setting, product development and verification testing from early-stage design through to pre-production.
 

Through his work on ‘smart’ injector projects, Kyle has acquired an interest in connected devices and how they can be utilised to improve Patient-Device interactions.

 

Louisa Harvey

Founder and Principal, Harvey Medical
Louisa Harvey

Louisa founded Harvey Medical Consulting in 2012, having worked in the pharmaceutical and medical device industry for over 15 years. She is passionate about usability of medical devices and, in 2018, co-founded Medical Human Factors Network whose mission is to raise the bar of human factors work in the UK. Louisa spends time both in the UK office and The Netherlands office.

 

Louisa also regularly presents at international conferences on the subject of device usability and ethics. Louisa has an MSc in Industrial Pharmaceutical Science and is an accomplished moderator, facilitating on average 600 interviews a year. Her project experience spans across many different products areas, from handheld auto-injectors through to large surgical systems. Louisa’s personable, can-do attitude and determination to get to the bottom of clients’ business questions, ensure that every project is a success!

Louise Place

Director, GSK
Louise Place

Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

Mark Hassett

Vice President of Business Development, Credence MedSystems
Mark Hassett

Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Block Medical, Medication Delivery Devices, Safety Syringes, Venetec Int’l, Unilife Medical, and ROVI Contract Manufacturing (EU).
His responsibilities included commercialization of infusion pumps, injectable devices (PFS), wearable devices, and autoinjectors.
He has injectable device experience in multiple markets to include, acute care, alternate site, and more specifically for Pharmaceutical and Biotech the last 20 years.
He holds a BS degree from Georgia State University in Atlanta, GA.
 

Matthew Jones

Senior Medical Sector Manager, DCA Design International
Matthew Jones

In his role as a Senior Sector Manager, Matt leads key projects within the Medical and Scientific Sector at DCA and works at a strategic level to help ensure that the Sector continues to develop and deliver success for DCA's clients.

A mechanical engineer by training, he has over 20 years' experience in consultancy and is a specialist in the development of drug delivery devices. He has extensive experience of leading multi-disciplinary teams and supporting clients through the all stages of the development process: from devising product strategies and roadmaps, through design and evaluation and on to detailed support of industrialisation and beyond.

Matt has device development experience that covers a wide range of technologies and routes of administration and as part of the talented team at DCA, has worked to deliver a number of multi-award winning and successfully marketed devices.
 

Montse Jansa

General Manager & Managing Director Denmark, Merck A/S
Montse Jansa

Montse Jansà is the Managing director in Merck Denmark with a strong background in pharma industry. With over 25 years of experience, Montse has proven expertise as a dynamic leader who delivers strategic thinking and goal setting.
Currently serving as the Managing Director in Merck Denmark, she is responsible for promoting and leading Merck footprint in Denmark, by leading local activities and gathering teams and functions around driving a high-performance culture, business transformation, and thriving in a challenging market access environment. Under her leadership, Merck Denmark has evolved into a more diverse and inclusive organization, with a strong focus on teamwork and feedback culture. We work hard everyday to bring more innovation and faster to Danish patients.
Prior to joining Danish team, Montse held several key positions in medical and commercial areas, including marketing manager, sales manager and Business Unit Head in Pfizer, Gilead and Merck.
Montse holds a degree in Biology from University of Barcelona, as well as a Master in General Management by IESE and several curses in leadership, digital business and communication and negotiation. She is also member of WILD, Women in Pharma and ADE.
Passionate about diversity in its broadest sense (gender, cultural and generational) and build up high performance teams.
In her free time, Montse enjoys hiking, reading and cooking.
 

Nicola Coles

Sustainability Director, BioPhorum
Nicola Coles

Nicola has been with BioPhorum since 2019. Initially focusing on raw materials, she has worked cross-phorum to connect the technical, supply chain, and regulatory experts to develop a strategy to future proof raw materials for the biologics industry. She now leads the newly launched BioPhorum Sustainability and is excited by the challenge to connect people from all disciplines across the industry around this critical topic.


A change program leader with over 25 years of management and consulting experience, Nicola has supported private and public sector organizations to improve results by aligning motivation, behaviors, and processes. Her passion is creating the link between executive strategy, technical capability, and front-line delivery, and developing comprehensive change programs underpinned by behavioral science techniques.


Her extensive project and change experience has been in banking, telecommunications, pharmaceuticals, and public services. As a result, Nicola has a wealth of insight in overcoming common change barriers, as well as deep expertize in industry specific challenges.
 

Niels Otterstrom Jensen

Head of TakeBack Program, Novo Nordisk
Niels Otterstrom Jensen

Niels Otterstrøm Jensen has a long standing experience in the pharmaceutical sector. After many years working within supply chain management in Novo Nordisk, he changed his position to Corporate Environmental Strategy in 2020, where he is Head of TakeBack Program. He is now leading a small team working on establishing take-back pilots of used injection pens. Until now take-back pilots have been launched in Denmark, UK, Brazil and France.

Oli Gould

Sustainable Solutions Lead, Owen Mumford Ltd.
Oli Gould

Oli Gould is an experienced Design Manager with a background in engineering and 10 years working in medical device development, preceded by several years working with household consumer technology brands. As R&D Sustainable Solutions Lead at Owen Mumford, Oli supports the development of innovative new medical devices. Alongside a range of competences, Oli specialises in engineering analysis and environmental sustainability in product development.

Pascal Lagorgette

Head of Product Development, Gerresheimer
Pascal Lagorgette

Pascal Lagorgette is Head of Product Development at Gerresheimer Advanced Technologies division in Switzerland. In this position he leads a team responsible for the development of smart on-body injectors. His passion for user-centric design, plus extensive experience developing innovative mechatronic devices, enable him to ensure that Gerresheimer’s solutions meet the needs of users and customers.

Peter Harley

Head of Technology, Crux Product Design Ltd
Peter Harley

Peter leads the Technology Group in Crux, containing the Applied Sciences and Electronics & Software teams. Working within the top pharma companies, he has supported projects across a wide range of topics related to challenges with injectable systems, as well as classic device design and development. With an enthusiasm to integrate the latest technology into device development to reduce time to market, he is experienced in supporting the inclusion of digital/simulation test data as regulatory evidence, as well as exploiting the latest scientific capabilities to unlock new insights to drive an enhanced patient experience.
Peter comes from an analytical research & development background, with a Masters in Mechanical & Manufacturing Engineering, a PhD in Turbomachinery Engineering, and 12 years of experience spread across automotive, consumer electronics, and medical devices.

Richard Crowther

Snr Manager Regulatory Affairs, Amgen
Richard Crowther

Richard has experience with a variety of companies (Procter & Gamble, GSK and Merck) but has spent the last 19 years with Amgen at the Thousand Oaks facility in California before recently moving back to the UK. At Amgen, Richard has lead teams in the engineering function, supporting drug substance manufacturing and later moved into process development, supporting drug product manufacturing. With his move back to the UK, Richard joined regulatory affairs, supporting device projects in the EU.

Sanjay Kumar Rout

Senior Manager, Device development and Technology Transfer of Medical Device Drug Device Combination Product, Biocon Biologics Ltd
Sanjay Kumar Rout

Relevant experience and Expertise : I have 17 yrs experience in Drug product manufacturing and Packaging, Combination device ( Pen and Autoinjector, NSG) development, process validation and commercialization, shipping validation. Expertise in Visual inspection, Packaging and medical device design and development , technology transfer and DHF filling.
 

Qualification: Bachelor in Pharmacy
 

Sean McPike

Global Product Stewardship Lead, Eli Lilly
Sean McPike

Sean worked in several heavy manufacturing industries before joining Eli Lilly in 2004, subsequently moving to a Global HSE role in 2007. Since that time, Sean has held a variety of Global Environmental Management roles including Subject Lead for Lilly’s EU & Asia Environmental Regulations and Lilly’s Global Chemical Regulations Compliance process. More recently, Sean is the Global Lead for Product Stewardship and Extended Producer Responsibility supporting Lilly’s Affiliates, Formulation, Packaging and Device Manufacturing facilities.
Sean is a member of the EFPIA EHS Expert Group and ABPIs SUSTAIN Group.
Sean received an MSc in Health, Safety and Environmental Management from University of Glamorgan in 1995 and gained Charter Environmentalist status in 2015.
 

Steve Hoare

Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)
Steve Hoare

Steven Malbon

Combination & Physical Devices Manager, Medical Engineering Technologies Ltd
Steven Malbon

Steven Malbon is a professional with 9 years of experience in the medical device industry. He currently serves as the Combination & Physical Devices Manager at Medical Engineering Technologies Ltd, where he oversees medical device testing projects from clients all around the world and is committed to ensuring that all products meet the highest standards of quality. In addition to his work at Medical Engineering Technologies Ltd, he is also a member of ISO Technical Committee 84, contributing to the advancement of medical device standards globally.

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Theresa Scheuble

Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.

Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.
 

Thomas Wejs Moeller

Director Global Regulatory Affairs - Device, Novo Nordisk
Thomas Wejs Moeller

Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products.
He has extensive experience with regulating medical devices in Denmark and Europe, and he comfortably balances between business aims and regulatory demands.
As a former Director of Medical Devices in the Danish Medicines Agency and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety.
Thomas has been elected Chair of the Competent Authorities for Medical Devices (CAMD). And has experience in national and international arenas—Europe with the EU commission, EMA, Notified Bodies, Authorities, and patient organisations.
Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.
 

Tina Arien

Associate Director, Janssen Pharmaceutica
Tina Arien

Albertina (Tina) Ariën is Principal Scientist in the Drug Product Development organization of Johnson and Johnson Innovative Medicine R&D in Beerse, Belgium. She has over 25 years of industry experience in small molecule formulation and process development. Her expertise is in liquid formulation development for oral and parenteral applications. The past 16 years she has worked on development of age-appropriate pediatric formulations. Her current focus is on developing complex injectable products such as long acting injectables and lipid-based formulations. Tina started working at J&J after a 2-year post-doctoral fellowship at the University of Nottingham. She received her Ph. D in Biomedical Sciences from the University of Bordeaux II. She graduated as a biochemical industrial engineer from University Hasselt.

Ulrich Stahl

Director New Technology, Harro Hofliger
Ulrich Stahl
  • Dipl. Ing / Mechanical Engineering at the technical university of Darmstadt
  • Project engineering and concepting for automation of injection moulding systems
  • Concept development and project engineering for cam operated assembly equipment / medical device industry
  • Director New Technologies at Harro Höfliger focussing on pharmaceutical and medical device industry products
     

What you will gain:

  • Opportunity to engage with pharma, biotech and device developers on the latest trends within the pre-filled syringe and injectable device market
  • Hear about new technological advances in the delivery of large volume drugs and novel drug products
  • Understand the latest regulatory requirements from experts surrounding medical devices and digital health
  • Gain insight into how big pharma is incorporating sustainable approaches into drug device design
  • Delve into the growing potential of digital health to improve patient experience and treatment
  • Explore key considerations for material components for the development of primary packaging

Why attend?

  • The only conference in Europe with 3 full days of dedicated injectable drug delivery presentations
  • 3 full days of networking opportunities
  • 40+ presentations with 70% of speakers from the top 20 big pharma companies
  • The agenda has been curated by an advisory board of big pharma, biotech and drug delivery editorial opinion leaders providing expertise focused on device development, regulatory affairs, human factors and digital health
  • A focus day and 4 dedicated streams addressing the hottest topics in the industry

 

 Who should attend?

Directors, Heads of Departments and Managers for the following areas:

  • Device Development
  • Device Engineering
  • Combination Product Development
  • Drug Delivery Devices
  • Primary Packaging Development
  • Digital Health
  • Sustainability and Circular Economy
  • Large Volume Drug Delivery
  • Novel Drug Product Formulation
  • Regulatory Affairs

This year's agenda has been validated by our 2024 advisory board:

Abha Violette, Associate Director Regulatory Affairs, AstraZeneca
Alphons Fakler, Director Human Factors Engineering/User Experience, Novartis
Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk
David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB
Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Device, Combination Products and eHealth, Bayer
Guy Furness, Proprietor and Publisher, ONdrugDelivery Magazine
Joel Richard, Chief Development Officer, Enterome
Khaudeja Bano, Vice President, Combination Product Quality, Amgen
Mitali Aon, VP and Global Head of Device Development, Sanofi
Steve Chamberlain, Director Device Engineering, GSK

 

sponsors

Conference agenda

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8:00

Registration & Coffee

The  Pre-Conference Focus Day on Advances in PFS Design for Enhanced Delivery will showcase cutting-edge innovations in pre-fi lled syringe and injectable combination device design and development. Industry experts will explore new technologies, innovative strategies in the design process and approaches to ensure safe and efficient product development. The session will emphasise developing robust, reliable and high-quality delivery devices through a risk-based approach and the development of effective control strategies. Given the growing demand for self-administration solutions, case studies will delve into patient-centric device development and opportunities for producing injection devices for the future.

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9:00

Chair's Opening Remarks

Elise Legendre, Head of Primary Container & Safety System Development, Sanofi

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9:10

Ensuring Effective Life Cycle Management of New Products

Alexander Prisacar, Scientific Expert for Devices, Boehringer Ingelheim

  • Outlining the LCM process for maintaining devices on market
  • Approaches for setting up an effective LCM strategy
  • Experiences and best practices to apply to your work

     

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    9:50

    Case study: PFS Development from Concept to The Shelf

    Anna Sawicki, Combination Product Design Control Lead, Pfizer R&D UK Limited

  • Insight into the development of a PFS and learnings from challenges encountered along the way
  • Insight into improving development efficiency and aligning design controls
  • Implementing a control strategy for EPRs
     
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    10:30

    Morning Coffee

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    11:00

    ADVISORY BOARD FIRESIDE CHAT: Producing Pre-Filled Syringes and Injectable Drug Devices for the Future

  • Collaboration and speed to market: How can teams across development, regulatory and quality work together to ensure speed to market ?
  • Worldwide launches: Sharing experiences, challenges and industry examples in regulatory submissions and multi-market launches. Our experiences and what can we as an industry do to ensure that our products meet patient needs worldwide?
  • Being ready for new technologies: Reviewing opportunities for advancing technology, expectations from market and ensuring stakeholder buy-in for the evolution of the injectables landscape. What can we proactively do to be ready for new technologies?
  • Patient needs: Ensuring we continue to meet our customer needs. What can we as an industry do to ensure we continue to understand and meet our patient needs world-wide?
     
  • Abha Raveau Violette, Associate Director, Devices and Digital Therapeutics, AstraZeneca

    Joel Richard, Chief Development Officer, Enterome

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    Alphons Fakler, Director Human Factors Engineering/User Experience, Novartis

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

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    11:40

    Advancements in Intravitreal Drug Delivery: the Past and the Future

    Hans Jensen, Business Development Leader, Cambridge Design Partnership

  • Brief intro and history of Intravitreal drug delivery devices
  • Challenges and unmet needs
  • The future: a glimpse into advancements and new technologies

     

     

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    12:20

    Networking Lunch

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    13:20

    Notified Body Submissions Under Combination Product Regulation

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

  • Experiences with the EU MDR as a former member of MDCG (authorities) and now heading Novo Nordisk RA devices
  • Outlining Challenges with article 117 in the MDR and gaining Notified Body Opinions
  • EMA/NB - and approvals vs. opinions
  • Where to be cognisant of gaps and how to move forward
     
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    14:00

    Industry perspective on design considerations for large volume and highly viscous drug delivery systems

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

  • Features
  • Delivery approaches
  • Patient and end user considerations
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    14:40

    Afternoon Tea

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    15:10

    Controlling Stability of Biologics During Product Lifecyle in PFS

    Joel Richard, Chief Development Officer, Enterome

  • Defining stability, biocompatibility, key quality attributes for submission to health authorities
  • Strategically generating a toxicology/immunogenicity risk assessment and mitigating risks in design by taking a risk- based approach
  • Complying with requirements for extractables and leachables
     
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    15:50

    Chair's Closing Remarks and Closing of Focus Day

    Elise Legendre, Head of Primary Container & Safety System Development, Sanofi

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    8:00

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

    David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

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    9:00

    Cooperation Scheme: Partnering Strategically to Advance Injectable Drug Device Recycling

    Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk

  • Insight into collaborating and forming strategic partnerships
  • Exploring the preparation process of the scheme
  • Delving into the current work of the partnership and update on the status of the pen injector takeback scheme
  • Challenges faced so far and how these have and can be overcome
  • Injector pen takeback schemes
     
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    9:30

    PANEL DISCUSSION: Collaboration is Key to Solve Highly Complex Sustainable Challenges

  • Further opportunities for collaboration to accelerate sustainability in industry
  • How can pharma and device manufacturers work together towards producing more sustainable injectors
  • How can industry, NHS and regulators work together and find scalable solutions to tackle waste to minimise the environmental footprint of injectable devices
  • Discussing the current barriers to strengthen collaboration to solve industry’s sustainability challenges
  • Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk

    Sean McPike, Global Product Stewardship Lead, Eli Lilly

    Oli Gould, Sustainable Solutions Lead, Owen Mumford Ltd.

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

    Claus-Juergen Maier, Circular Economy and Waste Lead, Sanofi

    Montse Jansa, General Manager & Managing Director Denmark, Merck A/S

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    10:00

    A Novel Prefilled Drug Delivery Platform: Expanding Access and Distribution

    Bo Kowalczyk, Chief Commercial Officer, ApiJect

  • Understand the ongoing impact of supply chain issues affecting the availability of sterile glass for prefilled injectable medicines, impacting market growth and access
  • Explore a technology platform that offers the advantages of prefilled syringes at the cost equivalent of single-use vials and syringes
  • Discover how a partnering solution can help differentiate existing marketed and approved injectable product lines amidst a competitive market landscape
  •  

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    10:30

    Morning Coffee

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    11:00

    Be prepared! Combination products under MDR (article 117)

    Heinrich Martens, Vice President Regulatory Affairs, Fresenius Kabi

  • MDR – Article 117 / Combination Products under MDR
  • What is a combination product
  • The meaning of Article 117
  • Manufacturer responsibilities evidence and fulfilment of the GSPRs
  • Notified Body Opinion
     
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    11:30

    Medical Device Simultaneous Engineering

    Ulrich Stahl, Director New Technology, Harro Hofliger

  • As medical devices seek to meet ever more challenging patient needs, they get more and more complex, and the industrialisation process is getting more complex.
  • The more innovative the device to meet these needs, the more likely that the assembly process is to require proof of principle work to become established.
  • If the medical device Developer just finishes their design and throws the problem “over the wall” into the Engineering department, delivery of the project can only be in series and likely to suffer serious delays as it is found, too late, that redesign is required. Instead simultaneous engineering with parallel working with a machinery supplier is recommended.
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    12:00

    Medical devices and in-vitro diagnostics used in drug clinical trials: principles of use and sponsor responsibilities under the medical device and IVD regulations requirements

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

  • Regulatory Landscape Changes
  • Overview of medical devices used in drug clinical trial
  • Sponsor responsibilities for medical devices used in the clinical trial according the requirements of MDR/IVDR
  • Combined trial and management of the dual submissions
     
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    12:30

    Next-Generation Device Development: From Data Capture to Actionable Insights

    Peter Harley, Head of Technology, Crux Product Design Ltd

  • Injection devices with embedded sensors capture real-world user behaviours
  • The influence of user inputs on drug performance
  • High-resolution medical imaging reveals never-before-seen mechanisms of drug-tissue interactions
  • Methods for correlating device design parameters with injection performance (bleb formation, pain, PK)
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    13:00

    Networking Lunch

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    14:00

    Chair's Opening Remarks

    Claus Geiger, Global Medical Device Project Leader, Sanofi

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    14:10

    Developing Injection Devices for Large Volume and Highly Viscous Therapeutic Proteins

    Claus Geiger, Global Medical Device Project Leader, Sanofi

  • Advances in establishing the optimal volume range for an on-body devices
  • Assessing the impact of viscosity on injection force and reducing intermolecular interactions
  • What does industry need to advance further? What is needed from vendors?
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    14:40

    Delivering large volume at home with a sustainable wearable injector platform

    Cecile Gross, Category Manager Parenteral, Nemera

  • Challenges of large volume drugs for the Industry
  • Addressing chronic diseases with large volume drugs
  • Challenges for delivering large volume injections at home
  • Drivers for designing a sustainable platform to address all these challenges
  • Necessity of a patient-centric approach
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    15:10

    Advanced modalities and formulation in the injectable space

    Tina Arien, Associate Director, Janssen Pharmaceutica

  • An overview of the current requirements effecting injectable drug product formulation
  • Challenges in high viscosity and high concentration formulation for injectables
  • Advances for injectable delivery >2ml and industry considerations
  • Challenges in development of injectable oligonucleotide therapies
     
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    15:40

    Afternoon Tea

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    16:10

    Bridging Human Factors Studies for Injectable Devices

    Ali Matour, Principal Device Engineer, GSK

  • Exploring bridging strategies
  • Using the threshold analyses to make decisions
  • Case study examples on human factors studies and bridging
  • Overcoming challenges
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    16:40

    Designing an on-body device to respond to the growth of biologic drugs

    Pascal Lagorgette, Head of Product Development, Gerresheimer

  • How the growth in biologics influenced the development of the Gx SensAir® on-body device
  • Design decisions for effective delivery of high viscosities and large volumes
  • Making sustainability an integral part of device design
  • The critical consideration of patient usability in home-care
  • Enhancing a device with connectivity to support patient adherence and monitoring
     
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    17:10

    Self-Injection: The Patient Journey

    Annie Zavadil

    Annie Zavadil, Device Project Leader, Novartis

  • Exploring the history of self-injection around diabetes
  • Outlining innovations and recent acceleration in the self-injection space
  • Optimising IFUs to aid the patient journey
     
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    17:40

    Chair's Closing Remarks and Close of Day One

    Claus Geiger, Global Medical Device Project Leader, Sanofi

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    14:00

    Chair's Opening Remarks

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

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    14:10

    The Regulator as an Enabler for Sustainable Medical Products

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

  • Placing patients’ interests and priorities first
  • Consult and Inform: “building compliance in”
  • What a medical devices regulator cannot do
  • Getting the Balance Right: Legislation, Guidance, Guidelines and advice
  • The Agency “Net Zero” Policy and next steps
     
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    14:40

    Sustainable Drug Delivery: The Device Supplier’s Perspective

    Chris Muenzer, Vice President Innovation and Development, Haselmeier

  • Role of the device supplier in the overall product sustainability
  • Benefits of lifecycle assessment (LCA) in device development
  • Trade-offs between usability, cost of goods, and carbon footprint
  • Challenging Pharma to close the circle and enable better solutions
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    15:10

    Circular Solutions for the Pharmaceutical Industry

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

  • A changing World
  • Towards Circular Materials and Products: Challenges and Opportunities
  • Enabling Transformative Change through Circular Solutions
  • Case Studies
     
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    15:40

    Afternoon Tea

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    16:10

    Measuring environmental impact – end of life use and carbon, an over-arching lens

    Courtney Soulsby, Global Director, Healthcare, BSI Group

  • Remanufacturing and reprocessing of medtech products – how to embed end of life use in the design process?
  • The need and align on the methodology that medtech companies use to evidence product level visibility of environmental impact
  • Comparing environmental impact categories for smart decision-making and evidencing to meet health systems’ requirements
     
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    16:40

    Thinking Big for Sustainable Devices

    Matthew Jones, Senior Medical Sector Manager, DCA Design International

  • Whatever your perspective on climate change, the necessity to improve the impact of products we use every day has become more pressing.
  • The medical sector has largely been exempted so far but this is changing. We are already starting to see sustainability becoming a major driver in the decision making of national governments and healthcare payers.
  • Opportunities to improve the environmental impact of injection devices exist in many aspects of their specification, design, manufacture, distribution, disposal and recycling. The challenge for everyone involved in device development, is to make sense of all these options.
  • We will summarise the strategies available to improve the sustainability of injection delivery devices and how best to implement them. We will provide guidance on which of the potential initiatives that could be put into practice are likely to be most effective. This will enable a hierarchy to be established that allows us to think big and prioritise the most effective options.
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    17:10

    Biophorum’s sustainability roadmap and what it means for drug delivery devices

    Nicola Coles, Sustainability Director, BioPhorum

  • Operating context for environmental sustainability in the healthcare sector
  • What this means for the biopharmaceutical industry and where the opportunities lie
  • Designing circular drug delivery devices -challenges and opportunities
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    17:40

    Chair's Closing Remarks and Closing of Day One

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

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    17:45

    End of Day One Networking Reception

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

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    9:10

    Impact of Regulatory change on Drug Device Combination Products

    Louise Place, Director, GSK

  • Recent learnings from MDR Implementation
  • Latest requirements for Drug Device Combination Products in the UK
  • Important considerations for making changes to established products
     
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    9:50

    The benefits of a smart device with a case study on SmartClic® development

    Kyle Berman, Principle Engineer, Pfizer Ltd

  • Comparisons between purely mechanical and smart injectors
  • The benefits of smart injectors to the Patient, Pharma company and Device Development Team
  • Evolution of the SMARTCLIC’s design, graphical user interface and packaging through preference and usability studies
  • Challenges faced during development of SMARTCLIC: learnings and takeaways to apply to connected injector development
     
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    10:30

    Morning Coffee

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    11:00

    PANEL DISCUSSION: Devices for the Future: Bringing value to both the patient and company

  • Striking a balance between a user-friendly device and a profitable asset to the company
  • Effectively balancing the level of connectivity with user needs
  • Practically and successfully gaining good user acceptance
  • How will the ecosystem evolve and what will patient care look like beyond the injector?
     
  • David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl

    Charles Potter, Technical Project Leader, Chiesi Ltd

    Cristiana Heese, P&L Development, Boehringer Ingelheim

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

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    11:40

    How to bring patient centricity into development of secondary packaging for combination products

    Cristiana Heese, P&L Development, Boehringer Ingelheim

  • Exploring new ways to enhance patient centricity in the development of secondary packaging for combination products
  • Plan and time Usability and UX activities right
  • Assess the interaction with Usability and UX during the development process
  • Opportunities to increase patient centricity in the development of secondary packaging
     
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    12:20

    Networking Lunch

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    13:20

    Chair's Opening Remarks

    Cinzia Rotella, Project Leader, Sanofi

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    13:30

    Selection of a new primary component: an interdisciplinary approach

    Cinzia Rotella, Project Leader, Sanofi

  • The project was about the selection of a new plunger stopper for 2 mL syringes for mAbs products inside Sanofi
  • The selection required a multidisciplinary effort from different departments: Development (MED - Medical devices), Procurement, Quality and Industrial department
  • The original approach that has been put in place for the project is now leveraged for other projects as an example of play to win behaviour inside the company
     
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    14:00

    Solutions for Emerging Challenges in Injectable Drug Delivery

    John Merhige, CEO, Credence MedSystems

  • Delivery of medications is moving from formal healthcare settings to the home
  • Injection volume ranges are broadening and viscosities are increasing
  • Solutions and suspensions risk needle clogging
  • Solutions are requiring reconstitution at the time of use
  • What solutions are available to address these challenges?
     
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    14:30

    Piston Placement in Prefilled Cartridges – The Journey is more important than the destination

    Richard Crowther, Snr Manager Regulatory Affairs, Amgen

  • Prefilled cartridges are a common primary container for drug product to be used in wearable injectors
  • Case study explores the factors influencing piston position in the drug product manufacturing process
  • Optimising the process development approach can reduce lead times into manufacturing
     
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    15:00

    Afternoon Tea

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    15:30

    A case study: Evaluation of Silicone Oil Free Pre-Filled Syringes

    Jacopo Michieli, Sr. Device Engineer, CSL Behring AG

  • Background and reason to choosing a SOF PFS system.
  • Selection process of potential options: Glass and Polymer syringe PFS.
  • Stability results with worst case molecule for drug container interaction.


     

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    16:00

    Understanding the ISO 11608 Series: Design and Testing of Needle-Based Injection Systems

    Steven Malbon, Combination & Physical Devices Manager, Medical Engineering Technologies Ltd

  • Providing comprehensive insights into 11608-1:2022, a crucial standard governing the design and testing of needle-based injection systems.
  • Gaining a deep understanding of the standard’s significance, design considerations, testing methodologies, and its impact on patient safety and product quality
  • Exploration of the standard’s key concepts, design guidelines, and testing protocols
     
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    16:30

    Optimisation of Stopper Position in PFS

    Sanjay Kumar Rout, Senior Manager, Device development and Technology Transfer of Medical Device Drug Device Combination Product, Biocon Biologics Ltd

  • Approaches to enable delivery of desired drug volume with appropriate glide force and break loose force
  • Gaining shipping validation for plunger stopper movement
  • Key considerations for autoinjector pen design to enable proper functioning
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    17:00

    Chair's Closing Remarks and Closing of Day Two

    Cinzia Rotella, Project Leader, Sanofi

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    13:20

    Chair's Opening Remarks

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

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    13:30

    Connecting the dots: Focus on connected delivery solutions

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

  • How are we moving from a product mindset to a solution one
  • What does it require to have focus on connected delivery solutions
  • Where is the industry now and where are we headed to?
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    14:00

    Partnerships and Collaborations in Digital Health

    Alex Russell, Digital Health Partnerships, Takeda

  • Examining the relationship between stakeholders- pharma companies and app/software developers
  • What makes a successful digital therapeutic collaboration?
  • How to ensure compliance to regulatory requirements
     
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    14:30

    Trends in Regulations of Digtial Health Technologies

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

  • How can digital health products be integrated into drug development
  • What are the regulatory challenges in implanting digital health technologies
  • What are the opportunities for harmonization on a global level
     
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    15:00

    Afternoon Tea

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    15:30

    Using Artificial Intelligence to Design an Enhance Injection Device

    Louisa Harvey, Founder and Principal, Harvey Medical

  • How responsible AI can revolutionize user research.
  • Novel research methodology.
  • Ethical considerations
     
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    16:00

    Chair's Closing Remarks and Closing of Day Two

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk


    Associate Director, Devices and Digital Therapeutics
    AstraZeneca
    Digital Health Partnerships
    Takeda
    Scientific Expert for Devices
    Boehringer Ingelheim
    Principal Device Engineer
    GSK
    Director Human Factors Engineering/User Experience
    Novartis
    Combination Product Design Control Lead
    Pfizer R&D UK Limited
    Device Project Leader
    Novartis
    Chief Commercial Officer
    ApiJect
    Category Manager Parenteral
    Nemera
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Technical Project Leader
    Chiesi Ltd
    Vice President Innovation and Development
    Haselmeier
    Project Leader
    Sanofi
    Global Medical Device Project Leader
    Sanofi
    Circular Economy and Waste Lead
    Sanofi
    Global Director, Healthcare
    BSI Group
    P&L Development
    Boehringer Ingelheim
    Director
    Novo Nordisk A/S
    Senior Director, Head of Device Manufacturing Partnerships
    UCB Biopharma sprl
    Head of Primary Container & Safety System Development
    Sanofi
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Senior Global Regulatory Professional
    Novo Nordisk
    Business Development Leader
    Cambridge Design Partnership
    Vice President Regulatory Affairs
    Fresenius Kabi
    Sr. Device Engineer
    CSL Behring AG
    Chief Development Officer
    Enterome
    CEO
    Credence MedSystems
    Senior Director
    AstraZeneca
    Principle Engineer
    Pfizer Ltd
    Founder and Principal
    Harvey Medical
    Director
    GSK
    Vice President of Business Development
    Credence MedSystems
    Senior Medical Sector Manager
    DCA Design International
    General Manager & Managing Director Denmark
    Merck A/S
    Sustainability Director
    BioPhorum
    Head of TakeBack Program
    Novo Nordisk
    Sustainable Solutions Lead
    Owen Mumford Ltd.
    Head of Product Development
    Gerresheimer
    Head of Technology
    Crux Product Design Ltd
    Snr Manager Regulatory Affairs
    Amgen
    Senior Manager, Device development and Technology Transfer of Medical Device Drug Device Combination Product
    Biocon Biologics Ltd
    Global Product Stewardship Lead
    Eli Lilly
    Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission
    Medicines and Healthcare products Regulatory Agency (MHRA)
    Combination & Physical Devices Manager
    Medical Engineering Technologies Ltd
    Head of Design & Innovation
    Johnson & Johnson
    Director Global Regulatory Affairs - Device
    Novo Nordisk
    Associate Director
    Janssen Pharmaceutica
    Director New Technology
    Harro Hofliger

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    Sponsors

    Exhibitors

    Official Media Partner

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    Preliminary Attendee List 2024

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    Meet me there! David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma

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    5 minutes with Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

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    5 Minutes with George Moore-Arthur Senior Global Regulatory Professional Novo Nordisk

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    Brochure

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    Sponsorship Prospectus

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    Letter from advisory board

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    Past Presentation: Carsten Worsøe, Novo Nordisk A/S

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    Past Presentation: Abha Raveau-Violette, AstraZeneca

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    Past Presentation: Shannon Clark, Userwise

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    Past Presentation: Petra Renné, Novartis

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    Past Presentation: M. Hemminger, Roche

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    Past Presentation: Ella Kimber, GSK

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    Past Presentation: Dr. Clemens Günther, Bayer AG

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    Past Presentation:Nima Aghaja Sanofi

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    Past Presentation:Cinzia Federico, Novartis

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    Past Presentation: Dr Kim Kristiansen & Dr Troels Keldmann

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    Past Attendee list

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    Sponsors and Exhibitors


    ApiJect™

    Gold Sponsor
    https://info.apiject.com/industry-events

    ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    Crux

    Gold Sponsor
    https://www.cruxproductdesign.com/

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..



    Harro Höfliger

    Gold Sponsor
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.


    Sponsors


    Cambridge Design Partnership

    Sponsors
    https://www.cambridge-design.com/

    Cambridge Design Partnership is an end-to-end innovation partner. We build breakthrough products and services – from insight to ideas, prototypes to production. Our Drug Delivery sector focus on injection systems including auto injectors, pen injectors, wearable (OBDS) devices and infusion pumps, as well as Digital Health applications including connected drug delivery devices, diagnostics/biomarker devices, app development and cloud services.


    CORMICA LTD

    Sponsors
    https://www.cormica.com/

    Cormica helps medical device manufacturers and pharmaceutical companies globally. Our one-stop-shop offers reliable testing services, including analytical chemistry, microbiology, and packaging testing. With GMP, GLP, ISO17025 certifications, we deliver high-quality testing and excellent customer service. Joined by Wickham Miro and Medical Engineering Technologies.



    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    DCA

    Sponsors
    https://www.dca-design.com/

    DCA offer comprehensive design, development and analysis solutions for the medical devices industry.

    Our multidisciplinary team offers an integrated, evidence based service focused on helping our clients achieve success through great product design.

    With a wealth of experience in developing leading injection devices for global markets, DCA’s work includes: variable dose pen injectors, single and multi-fixed dose injectors, disposable and reusable products, autoinjectors, wearable patch injectors, large volume injectors, connected and electro-mechanical devices.

    Our portfolio encompasses mass-market injectors that are manufactured in multi-billions, as well as lower volume devices targeting specific user populations and regional market needs. Alongside device design, we provide comprehensive support for industrialisation/production and create innovative instructions and product packaging solutions.

    Since 2000 our team have created over 1,700 granted patents for our clients. In the last 10 years we have received over 100 major design awards and supported our clients to launch more than 100 new products. We can provide expert support for device strategy, usability, due diligence, connectivity, mechanical engineering, electronics, medical device software, industrial design, UX/UI development, prototyping, industrialisation/production support, packaging and instruction design. We are certified to ISO13485 and work to ISO14971, IEC62304 and IEC62366.



    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence, focus on quality and customers. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.



    Owen Mumford

    Sponsors
    http://www.owenmumford.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

    For more information please visit https://www.ompharmaservices.com/


    Exhibitors


    Althena Medical

    Exhibitors
    http://www.althenamedica.it/

    Althena Medical is an Italian company specialized in the development and production of medical devices in the pharmaceutical field (pre-fillable syringes, oral liquid dispensers, droppers, etc.). In our catalogue we currently have COP pre-fillable syringes in several volumes. We also offer filling service and turn-key products.

    We work for small, medium and big brands for which we have designed, created and produced patented products.

    We differ from our competitors because we are flexible, reliable and we develop medical devices on demand very quickly.

    100% Made in Italy!



    IMA AUTOMATION

    Exhibitors
    https://imautomation.com/

    IMA AUTOMATION is the division of the IMA Group composed of leading companies in the automation and assembly industry, which designs and manufactures advanced technology solutions for handling and assembling parts in different industries. IMA AUTOMATION has a long experience in the medical industry, specifically for the assembly of Drug Delivery devices, Wearables and Diagnostics.

    At PFS 2024 X-PEN will be under the spotlight! Let our experts introduce you to our new technology, the standard modular platform for pen and autoinjector final assembly. With robust latest technologies, labelling as standard, quick time-to-market, compact design, standard machine bases and a fast ROI, our X-PEN systems use state-of-the-art technology: at your fingertips.



    MESA LABS

    Exhibitors
    https://mesalabs.com/

    Known globally for our experience and expertise, Mesa Labs manufactures ANSI/AAMI/ISO-, and USP-compliant indicators for a wide range of sterilization modalities. Our products and custom solutions offer convenient and consistent ways to validate and monitor the compliance of your processes and products.



    PHC Group

    Exhibitors
    https://www.phchd.com/global/ivd

    The PHC Group provides products and services for diabetes management, life sciences and diagnostics, as well as enhanced healthcare solutions that are used by patients, healthcare professionals and researchers in over 125 countries. By integrating digital solutions with our expertise in precision technology that has been nurtured over decades, we provide the best-in-class devices and services for advancing basic research, diagnosis and medical treatment.


    Prasfarma

    Exhibitors
    https://prasfarma.com/

    Prasfarma is a pharmaceutical company with more than 50 years of experience in the manufacturing of pharmaceutical products, specialized in oncology and HPAPI products. Prasfarma manufactures products based on the demand of its customers in a wide range of dosage forms such as PRE-FILLED SYRINGES, LYOPHILISED products, high potency products and also oral solid forms. Both cytostatics and non cytostatics.

    We are located in Barcelona with a manufacturing plant for Medical Devices of 15.000 sq meters, and a manufacturing plant for Drugs of 7.500 sq meters.

    Our facilities are adapted to manufacture pre-filled syringes of drugs (EU-GMP) and pre-filled syringes with Medical Devices (MDR).



    Syntegon Technology

    Exhibitors
    https://www.syntegon.com/

    Processing and packaging for a better life – this is what Syntegon works for every day. Be it individual machines, systems, or services, with intelligent and sustainable solutions Syntegon helps its customers in the global pharmaceutical and food industries to improve people's lives.

    FLEXIBLE AND SCALABLE SOLUTIONS FOR ASSEMBLY AND LABELING OF MEDTECH DEVICES

    Medical devices such as auto-injectors and pens contribute to beneficial patient outcomes, as they support easy administration and therapy adherence. Before the medication reaches the patients, the devices must be reliably assembled, labeled and packed. This is where the Syntegon solutions come into play: our systems cover the safe assembly, labeling, handling, and secondary packaging of medical devices. Thanks to their modular platform design, our manual, semi and fully automated systems allow for a high level of customization, helping you meet market requirements, while always having patient safety in mind.

    About Syntegon

    Syntegon Technology is a leading global process and packaging technology provider with 6,000 employees and annual sales of 1.3 billion euros. Syntegon Technology helps customers in the pharmaceutical industry to facilitate global access to safe medication. The comprehensive portfolio of intelligent technologies ranges from individual machines to complete lines for all process steps in the development, production, filling, inspection, assembly and packaging of liquid and solid dosage forms. Syntegon Technology supports pharmaceutical companies in project planning, development and implementation as well as with comprehensive digitization, qualification and validation services. In addition, customers have access to a global service network that provides support throughout the entire machine life cycle. The following product brands are included in the portfolio: Hüttlin, Klenzaids, Pharmatec, SBM Schoeller-Bleckmann Medizintechnik and Valicare.


    Media Partners


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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