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Pre-Filled Syringes and Injectable Drug Devices
10 January - 12 January 2023
Pre-Filled Syringes and Injectable Drug Devices

SAE Media Group’s 15th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
January 10 - 12 2023 | All Timings are GMT
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NEW FOR 2023:

Pre-Conference Focus Day: Advances in PFS Design for Enhanced Delivery


Main Conference Afternoon Streams
DAY 1: A) Novel Drug Products and Large Volume Delivery B) Sustainability for Injectable Delivery Devices
DAY 2: A) Primary Packaging Development B) Connected Delivery Devices
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The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to increase patient centricity, aid self-administration and deliver biologics that have large-volumes and novel formulations. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.


SAE Media Group's 15th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will be bigger than ever, with 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:


• Novel Drug Products and Large Volume Delivery
• Sustainability for Injectable Delivery Devices
• Primary Packaging Development
• Connected Drug Delivery Devices


With the injectable drug delivery industry growing exponentially year-to-year, administration using pre-filled syringes, auto-injectors, and pen-injectors are increasingly common. Innovations in device technology, such as smart devices are leading the way in device design in addition to injectable delivery devices for novel and long-acting therapeutics. We are starting to see environmental sustainability being incorporated into aspects of device manufacturing, design and the use of the device. This year’s conference looks to address the hot topics of the injectable drug delivery industry through case studies and industry insights.


This event will not only bring you key insights you need 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 2023.
 

FEATURED SPEAKERS

Aaron Gowson

Aaron Gowson

Public Affairs Manager, Chiesi Ltd
Abha Raveau Violette

Abha Raveau Violette

Associate Director, Devices and Digital Therapeutics, AstraZeneca
Adam Kalbermatten

Adam Kalbermatten

Vice President Commercial Development, Becton Dickinson (BD)
Bjorg Kaae Hunter

Bjorg Kaae Hunter

Director, Novo Nordisk
Blaine Martin

Blaine Martin

Director, Customer Success & Training, New Product & Portfolio Expansion, Merck KGaA
Blake  Green

Blake Green

Director Regulatory Affairs, Amgen Ltd
Carsten Worsoe

Carsten Worsoe

Principle Scientist Extractables and Leachables, Novo Nordisk
Cecile Gross

Cecile Gross

Global Category Manager - Parenteral, Nemera
Cedric Gysel

Cedric Gysel

Health Care Solutions Manager, Johnson & Johnson
Cinzia Federico

Cinzia Federico

New Technologies Device Project Leader, Novartis
Claus Geiger

Claus Geiger

Global Device Leader, Sanofi
Clemens Gunther

Clemens Gunther

Director, Senior Expert Nonclinical Safety, Bayer AG
Courtney Soulsby

Courtney Soulsby

Sector Development Director, Global Healthcare, BSI Group
Danielle Middleton

Danielle Middleton

Associate Medical Director, AstraZeneca
Eleanor Kimber

Eleanor Kimber

Principal Device Engineer , GlaxoSmithKline
Fatima Bennai-Sanfourche

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
Heinrich Martens

Heinrich Martens

Vice President Regulatory Affairs, Fresenius Kabi
Joel Richard

Joel Richard

Senior Expert and Former Chief Scientific Officer, Medincell
Jun Sato

Jun Sato

Product Manager, Zeon Europe GmbH
Kevin Kusmierek

Kevin Kusmierek

Senior Scientist Technical Device Leader, CSL Behring GmbH
Kim Anker Kristiansen

Kim Anker Kristiansen

Principal Scientist, LEO Pharma A/S
Klaus Boje

Klaus Boje

Scientist in Primary Packaging Development, Boehringer Ingelheim
Korey Johnson

Korey Johnson

Managing Partner, Bold Insight US, Bold Insight
Marc Moal

Marc Moal

Corporate Programme Vice President, Devices & Delivery Solutions, Novo Nordisk
Markus Hemminger

Markus Hemminger

Principal Device Engineer, Hoffmann-La Roche
Michael Becker

Michael Becker

Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Mitali Aon

Mitali Aon

VP and Global Head of Device Development, Sanofi
Niels Otterstrom Jensen

Niels Otterstrom Jensen

Head of TakeBack Program, Novo Nordisk A/S
Nima Aghajari

Nima Aghajari

Senior Simulation Engineer, Sanofi
Olaf Lebau

Olaf Lebau

Device Manager, Boehringer Ingelheim
Paul Draper

Paul Draper

Senior Sector Manager - Medical and Scientific, DCA Design International
Petra Renne

Petra Renne

Senior Expert Engineering, Packaging Technology, Novartis Pharma AG
Salim Bouaidat

Salim Bouaidat

Programme Director, Novo Nordisk A/S
Sean McPike

Sean McPike

Global Product Stewardship Lead, Eli Lilly
Sebastian Gerner

Sebastian Gerner

President, Alliance to Zero
Sebastian Stening

Sebastian Stening

Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG
Shannon Clark

Shannon Clark

Founder and Principal, UserWise
Steve Hoare

Steve Hoare

Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
Theresa Scheuble

Theresa Scheuble

Head Enterprise Design & Innovation, Johnson & Johnson
Tim Quigg

Tim Quigg

Development Director, Crux Product Design
Troels Keldmann

Troels Keldmann

DDS Device Consultant and Interim, Keldmann Healthcare A/S

Aaron Gowson

Public Affairs Manager, Chiesi Ltd
Aaron Gowson

Aaron has been leading the delivery of Chiesi's Leicestershire Take AIR (Take Action for Inhaler Recycling) pilot since 2021. The scheme enables inhaler users to recycle their empty, unwanted or out of date inhalers safely and effectively through the post. Any inhaler, brand and type, is accepted. Aaron has over 18 years’ experience working across the pharmaceutical industry and the NHS, helping healthcare to deliver the best treatments and outcomes for patients and the planet.

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.
 

Adam Kalbermatten

Vice President Commercial Development, Becton Dickinson (BD)
Adam Kalbermatten

Adam Kalbermatten leads the BD Pharmaceutical Systems Advanced Drug Delivery Commercial Development Team. Adam is focused on partnering with pharmaceutical and biotechnology companies to provide drug delivery solutions and services that help commercialize drug device combination product therapies.

Prior to joining BD, Adam served as Chief Executive Officer of ZebraSci, a combination product contract research and development organization (CRDO) acquired by BD in 2021. Prior to leading the ZebraSci organization, Adam held several leadership roles at Terumo, BD, and Merck. Adam holds a Bachelor of Engineering in Mechanical Engineering and a Master of Engineering in Engineering Management from Stevens Institute of Technology and an MBA from Columbia University.
 

Bjorg Kaae Hunter

Director, Novo Nordisk
Bjorg Kaae Hunter

Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK, UK in 2010 and has held different roles within the Device development field primarily in the late stage parenteral area. She has held positions with increased responsibility stating as device project lead for key GSK parenteral devices and progressing into leading a device management team, where she has had the accountability of project management and regulatory compliance for parenteral devices. Later Bjorg moved into a key management role in CMC regulatory where she was responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle. In 2020 Bjorg moved to NovoNordisk where she is Director of the RA Digital Health area within RA CMC and Devices. Bjorg has been very active in external advocacy especially related to combination products, connected devices and SaMD including driving industry positions in collaboration with industry working groups.

Blaine Martin

Director, Customer Success & Training, New Product & Portfolio Expansion, Merck KGaA
Blaine Martin

Since December 2013, I have led the Medical Device Customer Success & Training team within the Digital Health function based in Eysins, Switzerland, part of the Healthcare division of Merck Group, Darmstadt, Germany. I have worked with many culturally diverse teams to deliver engaging, easy-to-use digital solutions that foster innovation and help address unmet customer needs. Projects have included mobile digital health apps, patient education materials, innovative AR-based medical device training applications, global and local training programs, marketing communications and Web-based applications for biopharma, consumer goods and luxury brand industries.

 

Blake Green

Director Regulatory Affairs, Amgen Ltd
Blake  Green

 Blake Green is a Regulatory Affairs Director within Amgen’s Global Medical Devices Regulatory team. Based in the UK, Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.


 

Carsten Worsoe

Principle Scientist Extractables and Leachables, Novo Nordisk
Carsten Worsoe

Carsten Worsøe is a principal scientist within extractables and leachables (E&L) at Novo Nordisk. In over 24 years his main responsibility has been to analytical E&L documentation for container closure systems (vials, cartridges and pre-filled syringes), production materials and devices. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, production, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for E&L testing in development projects. In addition to that work, Carsten is a member of the E&L industry groups BioPhorum (BPOG), executive committee member in ELSIE (Extractables and Leachables Safety Information Exchange) and member of the EfPIA and Pharma ICH Q3E support groups.

Cecile Gross

Global 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

Health Care Solutions Manager, 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.

 

Cinzia Federico

New Technologies Device Project Leader, Novartis
Cinzia Federico

Cinzia holds a MSc degree in Pharmacy and a PhD from the University “Magna Graecia” of Catanzaro (Italy). During her studies and after as a Postdoc at the Washington University in St. Louis (USA), she focused on developing nanoparticles and biodegradable implants for application in gene delivery, tumor targeting and cancer therapy. In 2018, she moved to the ASST Spedali Civili di Brescia (Italy), where she worked on the analysis of transcriptomic aberrations within tumor-microenvironment in hematologic malignancies. Since 2019, she has been working at Novartis as a Drug Product Lead and Device Project Lead in Cell&Gene Therapy Technical Development.


 

Claus Geiger

Global Device Leader, Sanofi
Claus Geiger

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


Professional Experience:
Worked for top ten global pharma companies for more than 30 years. He started his career at Roche (Basel, Switzerland) and joined Sanofi in 1997. Since then has held various roles in the field of injectable drug delivery systems for biotherapeutics with expanding responsibility: 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, technical standardization of medical devices (ISO, DIN), establishing and working with cross-functional diverse teams.
 

Clemens Gunther

Director, Senior Expert Nonclinical Safety, Bayer AG
Clemens Gunther

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
He started his professional career in 1990 at Schering AG, Berlin-Germany.
From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.


Meanwhile Dr. Clemens Günther has gained over 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products in various medical indications.
 

Courtney Soulsby

Sector Development Director, Global 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. Working to understanding market challenges and future needs of the healthcare sector, Courtney works with key clients and industry partners to develop industry-wide strategies and programs of work. 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 medicines and med tech products.

Danielle Middleton

Associate Medical Director, AstraZeneca
Danielle Middleton

Danielle Middleton gained a BSc (Hons) in Medicinal Chemistry and a PhD in Organic Chemistry, prior to studying for her medical degree (MBBChir) at The University of Cambridge, UK. Danielle worked for 10 years in the NHS, gaining board certification in General Practice, before moving into industry. Initially as a Scientific Advisor MD, at Signant Health, and subsequently as an Associate Medical Director, Patient Safety Physician at AstraZeneca within the Devices and Digital Centre of Excellence. Danielle works collaboratively and cross functionally to provide medical/clinical input to device and/or digital programs, supporting device and digital programmes through the lifecycle from development to post-marketing.

Eleanor Kimber

Principal Device Engineer , GlaxoSmithKline
Eleanor Kimber


Eleanor Kimber holds an MEng in Biomedical Engineering from Queen Mary University of London, and has a background in medical device development, computational modelling and validation, and project management.

Prior to joining GSK in September 2020, she worked as one of the earliest members in a start-up developing breakthrough in vitro diagnostic technologies. Eleanor currently works in the R&D Device Engineering team as a Platform Lead for GSK's 1 mL parenteral devices.
 

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 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 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation.
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 euMDR 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 the medical Device regulation. The period of nomination is of five years starting on 01 March 2019.
 

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.

Joel Richard

Senior Expert and Former Chief Scientific Officer, Medincell
Joel Richard


Dr Joël Richard was previously Chief Scientific Officer (CSO) at MedinCell (Montpellier, France) where he is led the Research activities and the Pre-Clinical Drug Development activities of the company, based on the proprietary technology BEPO® for Long-Acting Injectables. (LAIs). These activities comprised of Research activities on new biomaterials and drug delivery technologies, CMC and Non-Clinical activities, supply of clinical batches, and quality and regulatory compliance. Dr Richard has more than 30 years of experience in chemistry and (bio)pharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Ipsen (France), Serono (Italy), MerckSerono (Germany), Ethypharm (France). Dr Richard has focused his research activity on new formulation technologies and innovative drug delivery systems (microspheres, nanosystems, self-assembling gels), especially for injectable peptide and protein formulations. He has graduated from Ecole Normale Supérieure (Cachan, France) and got a PhD in Materials Science (Paris VI, France). He has published 72 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields. He is the author of 140 international communications and 55 patent families. He has also been serving as an APGI Board Member for 3 years and is a Member of the Controlled Release Society (CRS).
 

Jun Sato

Product Manager, Zeon Europe GmbH
Jun Sato

Jun is Product Manager for Cyclo Olefin Polymers at Zeon Europe, and he is responsible for business development and marketing of Zeon Corporation’s highly transparent resins ZEONEX® and ZEONOR® in Europe. Since working at Zeon in 2011 experienced Logistics and Sales & Marketing for COP especially Optic devices in Japan, he joined Zeon Europe in November 2022. He is supporting the ambitious projects for COP business ahead in medical/pharma applications such as primary packaging in PFS & injectable drug devices.

Kevin Kusmierek

Senior Scientist Technical Device Leader, CSL Behring GmbH
Kevin Kusmierek

Kevin Kusmierek is a design engineer for combination products at CSL Behring. His current role spans from technical development to technical lifecycle management of existing products and maintaining a design verification lab. With a background as an experimental physicist, he draws from eight years of experience from testing and evaluating primary packaging and medical devices for pharmaceutical companies.

Kim Anker Kristiansen

Principal Scientist, LEO Pharma A/S
Kim Anker Kristiansen

Dr. Kristiansen has spent more than a decade in medical devices, the last 7 in LEO Pharma working with injection devices. He has held positions as senior medical device specialist, life cycle manager of marketed injection devices and currently hold a position as Device Technical Lead in early pipeline projects and Design Control Lead for AI in late pipeline projects. He partnered with Dr. Keldmann in the strategic work on platform selection for LEO Pharma and he headed the supplier evaluation and selection process. He is Principal Scientist and holds a M.Sc in Biology and a Ph.D in Cell Biology.

Klaus Boje

Scientist in Primary Packaging Development, Boehringer Ingelheim
Klaus Boje

Klaus Boje studied mechanical engineering. He has been working for Vetter as a supervisor
of the QC of packaging material. Since 1999 he is
working for Boehringer Ingelheim, first in the pharmaceutical development of biopharmaceuticals. Since 2014 he is a Scientist in primary packaging development and responsible for early and
late stage NBE and NCE projects for parenteral products.
 

Korey Johnson

Managing Partner, Bold Insight US, Bold Insight
Korey Johnson

Managing Partner and co-founder of Bold Insight, Korey has over 15 years of experience in UX and human factors (HF) research. He has a passion for making medical devices safer and more effective through the application of HFE/UE, as well as, establishing and maintaining an organizational culture that supports the development of expert HF practitioners. Korey began his career in automotive UX working at Daimler to improve the design of vehicle cockpits and in-vehicle systems. Korey developed and managed the medical device human factors practice for two UX research agencies, growing the medical device human factors practice from a handful of formative and summative usability tests each year to over 100 annual research and design engagements spanning the entire medical and drug delivery device development process. Korey is a contributing author to industry standards, regularly speaks at national and international conferences, and has an MS in Human Factors Psychology from the University of Idaho.

Marc Moal

Corporate Programme Vice President, Devices & Delivery Solutions, Novo Nordisk
Marc Moal

Marc is a multi-industry experienced leader who led major international programs (outsourcing, new product launch, new greenfield factory) in leading companies such as Swatch Group and Medtronic who then successfully built and led major R&D and Operations organizations in Heraeus, Nespresso and Merck. Now at Novo Nordisk since August 2021, he is in charge of the execution of the growing pipeline of Devices and Delivery Solutions in various therapeutic areas such as Diabetes, Obesity and Rare Diseases.

Markus Hemminger

Principal Device Engineer, Hoffmann-La Roche
Markus Hemminger

Markus Hemminger studied Chemistry at the University of Applied Sciences in Aalen, Germany, and is working as a Principal Device Engineer in the Device Development Department of Roche in Basel. He has more than 24 years experience in the area of injection devices and packaging components. Currently he is part of cross-functional teams developing prefilled syringes and devices for ocular injections where he is responsible for designing and specifying the components and determination of the design verification strategy. Before joining Roche in the year 2013 he was working as a Primary Packaging Engineer for biopharmaceuticals at Boehringer Ingelheim. His main expertise comprises selection, development and optimization of container closure systems and transfer-and administration devices, method- and process developments and CCI testing technologies. He holds several patents.

Michael Becker

Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Michael Becker

Dr. Michael Becker (born in 1983) is working at Boehringer Ingelheim Pharma GmbH & Co. KG since 2016 as a Design Engineer for parenteral combination products and for two years for packaging and labelling. Previously, he worked for 5 years at Sanofi-Aventis GmbH in the development of Autoinjectors, Pre-filled Syringes and Injection Pens. He studied Physics at the University of Mainz and wrote his PhD thesis about the Dry Powder Inhalers supervised by Mr. Prof. Cameron Tropea (Technical University Darmstadt).


 

Mitali Aon

VP and Global Head of Device Development, Sanofi
Mitali Aon

Mitali is a medical device and pharmaceutical executive with over 25 years of diverse experience spanning injectables, implantables, infusion and injection drug delivery devices. She has a successful track record of developing, industrializing and commercializing medical devices and combination products. Mitali is currently the VP and Global Head of the Medical Device Development unit at Sanofi. Prior to that she worked at companies such as Becton Dickinson, where she and her team were instrumental in developing and launching the first terminally sterilized prefilled syringe used for maintaining patency of VADs; as well as at Bristol Myers Squibb, where she established BMS’ device strategy, process, governance, quality system, and team structure to operationalize that strategy, leading to the launch of BMS’ first drug-device combination product. Mitali is a Biomedical Engineer by academic training, is six sigma green belt certified, and has several issued patents.

Niels Otterstrom Jensen

Head of TakeBack Program, Novo Nordisk A/S
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.

Nima Aghajari

Senior Simulation Engineer, Sanofi
Nima Aghajari

Education:

  • Master and PhD in mechanical engineering with a specialization in numerical simulation at Technical University Darmstadt (TUD)

Career:

  • Research Assistant at TUD (2009-2014): Development of simulation methods for aviation, automotive and medical engineering industries
  • Simulation Engineer at Sanofi (2014-Today)
  • Integration of state-of-the-art computational and analytical methods
  • Execution and supervision of critical simulation activities related to parenteral drug delivery

 

Olaf Lebau

Device Manager, Boehringer Ingelheim
Olaf Lebau

Lead Device Project Manager for Combination Products, Boehringer Ingelheim

Olaf is an applied physicist by training with a broad knowledge in interdisciplinary fields like nanotechnology and biomimetics, married with an interest in design and human psychology.
Over the years, he has worked on extracorporeal circuits, in vitro diagnostic, predictive algorithms and complex drug delivery systems.

At Boehringer Ingelheim, he is currently leading interdisciplinary teams, developing innovative delivery devices for new pharmaceuticals.

 

Paul Draper

Senior Sector Manager - Medical and Scientific, DCA Design International
Paul Draper

Paul is one of the senior management team at DCA servicing the medical sector. His 19 years of product development experience has been almost entirely on drug delivery device development projects. His mechanical engineering degree and years of experience working on and leading medical device projects culminates in the hands-on leadership of complex multi-disciplinary projects encompassing strategy, research, design, mechanical engineering, electronic engineering, software engineering and industrialisation. Paul has experience of low part count mechanical devices through to advanced electro-mechanical devices including IEC 62304 software development for embedded software and supporting mobile applications.

Petra Renne

Senior Expert Engineering, Packaging Technology, Novartis Pharma AG
Petra Renne

Trained as Biologist at University of Cologne, Germany.


After the PhD, Petra built her career in the pharmaceutical and life science industry at Servier Deutschland GmbH and Eurofins MWG GmbH between 2004 and 2013.


2013-2018 Technical Customer Support at West Pharmaceutical Services GmbH: primary packaging components, product recommendation, technical seminars.


Since 2018 Senior Expert Engineering Packaging Technology at Novartis Pharma AG: rubber components, SN PFS and currently leading the Delivery Technology Team for development of novel ophthalmic PFS solutions. Petra is passionate to improve the ivt delivery devices to improve ease of use and patient safety.
 

Salim Bouaidat

Programme Director, Novo Nordisk A/S
Salim Bouaidat

Salim Bouaidat, Programme Director - Devices & Delivery Solutions, holds a MSc (Eng) in Applied Physics and a PhD (EE) in Microtechnology both from the Technical University of Denmark. Salim has 10+ years of experience as leader within the medical device and drug delivery space. He joined Novo Nordisk A/S in 2006 and have held various leadership positions both in Denmark and the US, mainly focusing on leading medical device and SaMD (Software-as-Medical-Device) projects/programmes and the associated development teams through all phases of development.

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.
 

Sebastian Gerner

President, Alliance to Zero
Sebastian Gerner

Sebastian Gerner is President of the Alliance to Zero, and Innovation & Business Development Director with Ypsomed Delivery Systems. With more than 10 years of experience in the pharmaceutical and med-tech business he is currently driving the transition of Ypsomed from a linear take – make – waste economy towards a circular economy. As a core member of the sustainability board at Ypsomed he is as well responsible for designing the emission reduction pathway towards a net zero SBTi target on a corporate level.

Sebastian Stening

Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG
Sebastian Stening

Sebastian Stening is responsible for Late-Stage Development, New Product Introduction/ Industrialization and Life Cycle Engineering of Medical Devices and Drug-Device Combination Products at Bayer located in Berlin. To ensure efficient manufacturability, the mission of the Medical Device Manufacturing Science and Technology Organization is an end-to-end integration of product, process, and automation designs.
Prior to Bayer, he worked for Sanofi in various positions in Medical Device and Drug-Device Combination Product Development, Industrialization, and Manufacturing.
Sebastian holds a M.Sc. in Business Engineering focused on Physics and Medical Device Technologies from the University of Applied Science Muenster (Germany).

 

Shannon Clark

Founder and Principal, UserWise
Shannon Clark

Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.

 

Steve Hoare

Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
Steve Hoare

Steve Hoare was previously the Policy Director, Quality, Regulatory Science and Safety at the Association of the British Pharmaceutical Industry.


An analytical chemist by training, Steve Hoare has spent most of his career leading quality functions within pharmaceutical companies.
 

His experience covers the full lifecycle of medicines from early drug discovery through to manufacture, supply, and now on circularity. In his previous role, Steve led policy development in both sustainability and regulatory science for the ABPI. Steve continues to work with other stakeholders on both a UK ePI Taskforce and a Roadmap for medicines packaging recycling in the UK.
 

Theresa Scheuble

Head Enterprise 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.

 

Tim Quigg

Development Director, Crux Product Design
Tim Quigg

Development Director at Crux with over 10 years of industrial experience. Tim has enviable experience across a wealth of medical device and combination product platforms including asthma inhalers, pre-filled syringes, pen/auto-injectors, on-body/large-volume and connected devices. With a focus on evidence-led device development, he champions early-stage feasibility assessment through data-driven design and quantitative evaluation. This work includes computational simulation & modelling, instrumented data-capture, eye-tracking and early adoption of enabling technologies, ensuring that potential solutions are efficiently assessed and qualified, confirming performance prior to detailed design, prototyping and tooling. Today, Tim supports novel device design programmes with multi-national stakeholder groups, acting as a trusted advisor and technical reviewer to support the wider Crux team.

Troels Keldmann

DDS Device Consultant and Interim, Keldmann Healthcare A/S
Troels Keldmann

Dr Keldmann has spent 25 years in DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR-strategy, business development, partnering and commercialization. As Interim Technical Lead on Injection Devices, LEO Pharma A/S, he headed identification, evaluation and selection of SC injection devices. Prior DDS experience include co-founding & heading innovative DDS startups, and consultant in DDS devices for pulmonary, nasal, SC (needle/needle-free) and IM delivery. He is appointed Business Coach by European Innovation Council EIC and Industry Fellow at Technical University of Denmark. He holds a B.Sc, M.Sc. and Ph.D. in Mechanical Engineering & Innovation, and MBA.

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Chair's Opening Remarks

Mitali Aon, VP and Global Head of Device Development, Sanofi

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9:10

Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology

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

  • Historical review of various routes of administration
  • Role of the Patient driving changes in delivery approaches
  • Convergence of Drug Development and Minimally Invasive procedures
  • Examples of Current and Future Technologies
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    9:50

    Quality by Design: Enhancing Safety, Efficacy and Manufacturability of your PFS

    Sebastian Stening, Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG

  • Introduction to the quality by design framework
  • How to maximise product safety and manufacturing efficacies
  • Insight into improving development efficiency and aligning design controls
  • Example Quality by Design Approach
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    10:30

    Morning Coffee

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    11:00

    A blueprint for patient-centric drug delivery device development

    Olaf Lebau, Device Manager, Boehringer Ingelheim

  • New molecular formats enable a new range of modalities but bring additional requirements for drug delivery
  • A blueprint for a device development process which is independent of disease, drug, and device type
  • Clinical Study Designs with Fast to Clinic Delivery Device Platforms
  • Guide Patient Insights and Customer Centric Design Paradigms into Device Platforms
  • How to aggregate User needs, technical Requirements, Business requirements, Manufacturing Requirements, and development requirements for key decision criteria
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    11:40

    Combination Products in Global Market: Regulatory Approach

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

  • Regulatory development in global market
  • Effective collaboration and speed to market
  • Case Studies
  • Key learnings and take away
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    12:20

    Networking Lunch

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    13:20

    Using Simulations to improve Combination Product Designs

    Nima Aghajari, Senior Simulation Engineer, Sanofi

  • Use of simulations to understand the design of combination products
  • Insight into modelling analysis and digital perspective on assembly processes evaluation
  • Lessons learned: Challenges of a machine guided product assembly process
  • Challenges faced and further advancing design with simulation
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    14:00

    Challenges of long-acting injectable delivery of fragile molecules

  • An industry outlook of long-acting injectable technologies and unmet needs for delivery technologies
  • Competitive advantages of in situ forming implant technologies
  • Overcoming challenges of molecular structure and stability for fragile molecule delivery
  • Examples of current approaches for delivery of fragile molecules like peptides and proteins
  • Joel Richard, Senior Expert and Former Chief Scientific Officer, Medincell

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    14:40

    Afternoon Tea

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    15:10

    Overcome challenges of intravitreal (IVT) injections with low volume ophthalmic pre-filled syringes (PFS)

    Petra Renne, Senior Expert Engineering, Packaging Technology, Novartis Pharma AG

  • User experience during preparation and application of IVT injections
  • Patient safety during IVT injections
  • Parameters of the manufacturing process of low volumes inophthalmic PFS
  • Investigating of glass versus polymer PFS
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    15:50

    Chair’s Closing Remarks and Close of Focus Day

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    8:00

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry

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    9:10

    Case study: Strategic selection of injection device platform and suppliers: Why and How

  • Strategic importance of Drug Delivery System (DDS) selection
  • Background and timing for initiating the DDS device decision making process
  • Cross-functional approach for evaluation and selection of device DDS options
  • Facilitating and completing the strategic decision process
  • Kim Anker Kristiansen, Principal Scientist, LEO Pharma A/S

    Troels Keldmann, DDS Device Consultant and Interim, Keldmann Healthcare A/S

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    9:40

    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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    10:10

    Extending Adoption: Maximising the value of ubiquitous simulation and modelling

    Tim Quigg, Development Director, Crux Product Design

  • Product studies - Understanding and optimising device performance
  • Production evaluations - Using digital evidence for production scale-up and commercialisation de-risking
  • Processing investigations - Deploying analytical tools across the supply-chain
  • Anatomical modelling - State-of-the-art in drug-device-tissue interaction assessments
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    10:40

    Morning Coffee

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    11:10

    What does the Future Hold for Pre-Filled Syringes and Injectable Drug Devices

  • How can we enhance partnerships across inter-departmental teams and with suppliers throughout device development and post-launch?
  • Sharing challenges in regulatory submissions and examples of industry experiences to help you overcome these
  • As we look to advance technology and innovations, how can we ensure stakeholder buy-in for the evolution of the injectables landscape?
  • What are the expectations from market?
  • Sustainability as a driver for advancing technology and innovations?
  • Looking at providing smart solutions for the future: what are the benefits of connected health?
  • Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry

    Bjorg Kaae Hunter, Director, Novo Nordisk

    Joel Richard, Senior Expert and Former Chief Scientific Officer, Medincell

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    11:40

    Developing Sustainable Practices for your Injectable Portfolio

  • The current landscape and industry movement towards a circular economy
  • Examples of current approaches and critical steps to introduce recycling to the device delivery industry
  • How can the supply chain be optimised?
  • An outlook to the coming years of sustainability and how pharma can implement recycling for drug delivery devices
  • Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry

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    12:10

    Panel Discussion: Collaborating to Advance Sustainability in the Pharmaceutical Industry

  • How can the pharma industry and other stakeholders collaborate to advance sustainability?
  • What are the biggest challenges we are facing and what can be done to overcome them?
  • Takeaways from beyond the pharma industry: what can we learn?
  • Sebastian Gerner, President, Alliance to Zero

    Cedric Gysel, Health Care Solutions Manager, Johnson & Johnson

  • How can the pharma industry and other stakeholders collaborate to advance sustainability?
  • What are the biggest challenges we are facing and what can be done to overcome them?
  • Takeaways from beyond the pharma industry: what can we learn?
  • Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk A/S

    Aaron Gowson, Public Affairs Manager, Chiesi Ltd

    Sean McPike, Global Product Stewardship Lead, Eli Lilly

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    12:40

    Networking Lunch

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    13:40

    Day One Afternoon Parallel Streams

    STREAM A: Novel Drug Products and Large Volume Delivery STREAM B: Sustainability for Injectable Delivery Devices

    13.40 Chair’s Opening Remarks
     

    Claus Geiger, Global Medical Device Leader, Sanofi

    View Bio

    13.40 Co-Chair’s Opening Remarks
     

    Cedric Gysel, Healthcare Solutions Manager, Johnson and Johnson

    13.50 Developing Wearable Injectors for Large Volume and Highly Viscous Drugs

  • An insight into the current landscape and examples large volume wearable injectors on the market
  • Establishing the optimal volume range for an on-body device
  • Assessing the impact of viscosity on injection force and reducing intermolecular interactions
  • Case study on a wearable injector: delivering monoclonal antibodies 

     

    Claus Geiger, Global Medical Device Leader, Sanofi

  • 13.50 Recycling Injectable Drug Devices: An Update

  • Discussion of creating end-of-life product solutions such as take-back pilots
  • Exploring the current challenges in re-purposing drug delivery devices
  • How can the challenges in launching take-back schemes be overcome?
  • Case Study on a real-world TakeBack Program and key takeaways
  • How can these programs be scaled-up?   

     

    Niels Otterstrøm Jensen, Head of TakeBack Program, Novo Nordisk A/S Reusable devices

  • 14.20 Delivering large volume at home with a sustainable wearable injector platform

  • 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

    Cecile Gross, Category Manager for Parenteral Devices, Nemera

  • 14.20 Applying Circularity: Moving Towards Net Zero Drug Delivery Devices

  • Introduction to Alliance to Zero’s mission and work
  • Practical ways to calculate a product’s carbon footprint and assess the product life cycle
  • Strategic approaches to enable circular transformation
  • How stakeholders can collaborate to effectively develop more sustainable injection devices? Sebastian Gerner, President, Alliance to Zero
  • Stream Chairs:

     

     

     

    Claus Geiger, Global Device Leader, Sanofi

    Cedric Gysel, Health Care Solutions Manager, Johnson & Johnson

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    14:50

    Afternoon Tea

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    15:20

    Day One Afternoon Parallel Streams Continued

    STREAM A: Novel Drug Products and Large Volume Delivery Cont STREAM B: Sustainability for Injectable Delivery Devices Cont

    15.20 Platform Approaches to increase the Efficiency of your Injectable Portfolio

  • What delivery systems and devices are suitable for platforms and tailoring for a range of delivery volumes
  • Proven risk, clinical and usability testing for a successful platform
  • Challenges in using platforms for novel drug products and assessing when a platform is most beneficial for a product portfolio
  • How can platforms be utilised to maximise product success: A case study
     

    Eleanor Kimber, Principal Device Engineer, GSK
     

  •  15.20 Embedding sustainability into medical device product life cycle

  • Incorporating eco-design and circular economy into products
  • Standards for consistency in approach
  • Current barriers - are there any and how can they be overcome
  • Assurance for greater recognition and credibility

    Courtney Soulsby, Sector Development Director, Global Healthcare, BSI Group

     

     

  •  15.50 Integrated drug device combination product development for large volume subcutaneous delivery

  • Combination product development can involve trade-offs
  • Choices can influence where risks may reside
  • BD Portfolio of solutions (products and services)
  • BD partnering and capabilities that bring solutions to clinic and to commercialization

    Adam Kalbermatten, Vice President of Commercial Development, BD

  •  15.50 Sustainable solutions: circular materials and end of life thinking
  • Exploring innovations in packaging: plastic free
  • Discussion of product end of life solutions
  • Case study on the work being done at Johnson and Johnson
  • Challenges with new technologies: wearable injectors containing electronics and batteries
  • The future need for collaboration to enhance sustainability throughout the drug device industry

    Cedric Gysel, Healthcare Solutions Manager, Johnson and Johnson

  • 16.20 Human Factors and Clinical Use Testing

  • When does the U.S. FDA expect actual use human factors testing?
  • How to decide when simulated use is sufficient for your human factors program
  • What are some common pitfalls when working with a traditional CRO to conduct Actual Use testing? Shannon Clark, Founder and CEO, UserWise
     
  •  

     Stream Chairs:

     

     

    Claus Geiger, Global Device Leader, Sanofi

    Cedric Gysel, Health Care Solutions Manager, Johnson & Johnson

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    16:50

    Day One Afternoon Parallel Stream Chair Closing Remarks and Close of Day One

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    17:00

    End-of-Day-One Networking Reception

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    8:15

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

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

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    9:10

    Extractables and leachables assessment in PFS drug products

    Carsten Worsoe, Principle Scientist Extractables and Leachables, Novo Nordisk

  • Choice of critical components for drug compatibility in PFS
  • Predictive tools for interactions in PFS
  • Considerations for PFS platforms
  • Case studies on leachables assessments in prefilled syringes
     
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    9:40

    Sustainable, optimized packaging platform development for drug/device combination portfolio

    Michael Becker, Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG

  • Defining a packaging platform as an answer to a broad drug/device combination portfolio
  • Major challenges during the platform development
  • Material selection, platform variability and add-on features under the aspects of value proposition, product individualization, economy, and ecology
  • Reducing complexity and risk during the design and process development as well as for the transfer by using a packaging platform
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    10:10

    Evaluation of a second source for a pre-filled syringe

    Klaus Boje, Scientist in Primary Packaging Development, Boehringer Ingelheim

  • Comparison of commercially available PFS qualities
  • Selection criteria
  • Case study: How to deal with challenges
     
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    10:40

    Morning Coffee

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    11:10

    Cell & Gene Therapy: Best Practices for an Evolving Drug Product Portfolio

    Cinzia Federico, New Technologies Device Project Leader, Novartis

  • An update on the landscape of cell and gene therapy and identifying when injectable delivery is the appropriate approach
  • Assessing the impact of COVID and the use of frozen PFS
  • Potential benefits and challenges of a parenteral approach to delivery of cell and gene therapies using pre-filled syringes
  • Future development strategies for cell and gene therapy
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    11:40

    Centralising Scientific and Medical Input for Patient Safety Considerations with Innovative Device Technologies

    Danielle Middleton, Associate Medical Director, AstraZeneca

  • Insight into centralising device input and supporting the development of medical devices
  • Case study on the process of device development leveraging a centralised patient safety team
  • Critical considerations for the safety of medical devices
     
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    12:10

    Panel discussion: Harmonising global device regulations: producing a product for a global market

  • Discussion of the varying regulations across the US, Europe, China and Japan
  • Defining terminology to harmonise understanding throughout the industry
  • How can collaboration between stakeholders be improved to overcome these challenges in variation?
  • What are the emerging markets and what can we expect moving forward?

     

  • Blake Green, Director Regulatory Affairs, Amgen Ltd

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

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

    Shannon Clark, Founder and Principal, UserWise

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    12:40

    Networking Lunch

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    13:40

    Day Two Afternoon Parallel Streams

    STREAM A: Primary Packaging Development STREAM B: Connected Drug Delivery Devices
    13.40 Chair’s Opening Remarks
    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer

    13.40 Chair’s Opening Remarks
    Bjorg Hunter, Director, Novo Nordisk

    13.50 A New Approach for Container Closure Integrity Testing of Prefilled Syringes

  • Aim of new CCI test method addressing unmet questions
  • Method development approach
  • CCI robustness testing
  • Potential of new test method

    Markus Hemminger, Principal Medical Device Engineer, Roche

  • 13.50 Risk Management for Connected Delivery Devices

  • Assessing the EU MDR requirements on device risk management process
  • Impact of usability engineering and human factors
     

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Device, Combination Products and eHealth, Bayer

  • 14.20 Technical overview of COP for Pharma Packaging

  • The advantages and key properties of Cyclo Olefin Polymers in plastic primary packaging
  • About Protein Adsorption/Aggregation
  • Study on Nucleic Acid Adsorption

    Jun Sato, Product Manager, Zeon

  • 14.20 Principles of successful connected injection device development

  • Introduction to key aspects of device development that are critical to the success of connected devices
  • Examples of key challenges that need to be overcome and how the key aspects are interwoven
  • Thoughts to take away on what are the most important factors for success and how the challenges can be overcome

    Paul Draper, Senior Sector Manager - Medical and Scientific, DCA Design

  •  Stream Chairs:

     

     

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG

    Bjorg Kaae Hunter, Director, Novo Nordisk

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    14:50

    Afternoon Tea

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    15:20

    Day Two Afternoon Parallel Streams Continued

    STREAM A: Primary Packaging Development Cont STREAM B: Connected Drug Delivery Devices Cont

    15.20 Safety Assessment of Nitrosamine Impurities

  • Interpreting the updated guidance on nitrosamines: what does industry need to consider?
  • What are acceptable limits for nitrosamines in drug products?
  • Understanding the sources of the impurities and how to avoid them
  • Risk assessment on nitrosamines from a toxicology perspective

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer

  • 15.20 Digitisation of injection systems: recent successes in the field of Diabetes

  • Introduction to what can digitalisation bring as value in Diabetes
  • Case study of a connected pen, first learnings
  • Case study of a DTX algorithm, first learnings
  • Looking into the future of digitalisation for diabetes Marc Moal, Corporate Programme Vice President, Devices and Delivery Solutions, Novo Nordisk

    Salim Bouaidat, Programme Director, Novo Nordisk

     

  •  15.50 Document improvements to your instructions for use with this framework

     

  • Understand a driver of regulator requests for additional information when reviewing human factors protocols and submissions of combination products.
  • Learn how to quickly and easily evaluate the content and design of your instructions for use for adherence to best practices in informational and user-centered design, as well as how they follow regulator-published prescriptive and directional recommendations for content and format of combination product labelling.
  • Facilitate more effective and productive discussions with cross-functional team members, including regulatory, by referencing a framework to promote adherence to underlying principles rather than prescriptive recommendations where appropriate. Korey Johnson, Managing Partner, Bold Insight US

     

  • 15.50 Creating a user centric digital health product: Technology and Design considerations

  • Critical considerations for patient experience and how emerging technologies can enhance patient adoption and adherence
  • Understanding and implementing behaviour design into development to develop products that are user centric
  • Case study on the development of a user centric digital health product
  • Accurately establishing documented evidence that the software is installed correctly, meeting user needs and function according to intended use 

    Blaine Martin, Digital Health, New Product Planning and Portfolio Expansion, Franchise Lead, Fertility, Merck
     

  •  16.20 Challenges of sWFI vial replacement with sWFI PFS during product lifecycle

  • Requirements of co-packaging vs integrated drug device combination
  • Essential performance requirements vs critical quality attributes
  • Guiding CMOs through root cause investigations Kevin Kusmierek, Scientist, Primary Packaging and Medical Devices, CSL Behring
  •  

    Stream Chairs:  

     

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG

    Bjorg Kaae Hunter, Director, Novo Nordisk

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    16:50

    Day Two Afternoon Parallel Stream Chair Closing Remarks and Close of Day Two


    Public Affairs Manager
    Chiesi Ltd
    Associate Director, Devices and Digital Therapeutics
    AstraZeneca
    Vice President Commercial Development
    Becton Dickinson (BD)
    Director
    Novo Nordisk
    Director, Customer Success & Training, New Product & Portfolio Expansion
    Merck KGaA
    Director Regulatory Affairs
    Amgen Ltd
    Principle Scientist Extractables and Leachables
    Novo Nordisk
    Global Category Manager - Parenteral
    Nemera
    Health Care Solutions Manager
    Johnson & Johnson
    New Technologies Device Project Leader
    Novartis
    Global Device Leader
    Sanofi
    Director, Senior Expert Nonclinical Safety
    Bayer AG
    Sector Development Director, Global Healthcare
    BSI Group
    Associate Medical Director
    AstraZeneca
    Principal Device Engineer
    GlaxoSmithKline
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Vice President Regulatory Affairs
    Fresenius Kabi
    Senior Expert and Former Chief Scientific Officer
    Medincell
    Product Manager
    Zeon Europe GmbH
    Senior Scientist Technical Device Leader
    CSL Behring GmbH
    Principal Scientist
    LEO Pharma A/S
    Scientist in Primary Packaging Development
    Boehringer Ingelheim
    Managing Partner, Bold Insight US
    Bold Insight
    Corporate Programme Vice President, Devices & Delivery Solutions
    Novo Nordisk
    Principal Device Engineer
    Hoffmann-La Roche
    Packaging Engineer
    Boehringer Ingelheim Pharma GmbH & Co. KG
    VP and Global Head of Device Development
    Sanofi
    Head of TakeBack Program
    Novo Nordisk A/S
    Senior Simulation Engineer
    Sanofi
    Device Manager
    Boehringer Ingelheim
    Senior Sector Manager - Medical and Scientific
    DCA Design International
    Senior Expert Engineering, Packaging Technology
    Novartis Pharma AG
    Programme Director
    Novo Nordisk A/S
    Global Product Stewardship Lead
    Eli Lilly
    President
    Alliance to Zero
    Vice President and Global Head Medical Device Manufacturing Science and Technology
    Bayer AG
    Founder and Principal
    UserWise
    Consultant and Former Quality, Regulatory Science & Safety Policy Director
    Association of the British Pharmaceutical Industry
    Head Enterprise Design & Innovation
    Johnson & Johnson
    Development Director
    Crux Product Design
    DDS Device Consultant and Interim
    Keldmann Healthcare A/S

    Gold Sponsor

    Sponsors

    Exhibitors

    Key Media Partners

    Supporters

    Short Agenda

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    Preliminary Attendees 2023

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    Full Agenda

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    Speaker Interview - Abha Raveau Violette - AstraZeneca

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    Speaker Long Video Interview - Sebastian Stening - Bayer AG

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    Speaker Short Video Interview - Sebastian Stening - Bayer AG

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    Interview with Marc Moal, Corporate Programme Vice President, Devices & Delivery Solutions, Novo Nordisk

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    Sponsorship Prospectus

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    Conference Brochure

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    Past Speaker Presentation - Raphael Nudelman - Teva

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    Past Speaker Presentation - Julia Frese - TUV SUD

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    Past Speaker Presentation - Eleanor Kimber - GSK

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    Past Speaker Presentation - Richard Simcock - Teva

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    Past Attendees List

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    Pre-filled Syringes and Injectable Drug Devices Worldwide Survey 2022

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    Speaker Biographies

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    Advisory Board Welcome Letter

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    Sponsors and Exhibitors


    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..


    Sponsors


    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Bold Insight

    Sponsors
    https://boldinsight.com/

    Bold Insight is a UX and human factors research agency based in London and Chicago. Executing projects across the product development lifecycle, we conduct user research informing early product design to global human factors validation. We work with digital, next-generation technology—medical devices to mobile apps, IFUs to customer journeys.



    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.



    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.



    ZEON

    Sponsors
    https://www.zeon.eu/

    ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Credence MedSystems

    Exhibitors
    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.


    Gerresheimer

    Exhibitors
    http://www.gerresheimer.com

    Gerresheimer is the innovative system and solution provider and global partner for the pharma and biotech industry. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets. With over 11,000 employees, the company generated revenues of around €1.82bn in 2022. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).


    Harro Höfliger

    Exhibitors
    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.



    Haselmeier

    Exhibitors
    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.



    Owen Mumford

    Exhibitors
    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/



    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.

    Media Partners


    Gene Therapy Net

    Key Media Partners
    http://www.genetherapynet.com

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    World Pharma News

    Key Media Partners
    http://www.worldpharmanews.com/



    Mednous

    Key Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharma Journalist

    Key Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Pharmiweb

    Key Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Pharmaceutical Technology

    Key Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Technology Networks

    Key Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    World Pharma Today

    Key Media Partners
    http://www.worldpharmatoday.com



    ASD MEDIA

    Key Media Partners
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Pharmacircle

    Key Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    evvnt Ltd

    Key Media Partners
    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    ONdrugDelivery Magazine

    Key Media Partners
    http://ondrugdelivery.com

    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.


    pharmaphorum

    Key Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com

    Media Partners


    Raumedic

    Supporters
    http://www.raumedic.com

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design



    10 times

    Supporters
    http://10times.com

    10Times connect professionals with right information & people at the right place and time. Our name defines our audience & vision: Help Business Professionals grow. Events bringing together the right ingredients to generate value for the target audience. Over 2 million professional events are hosted for various topic, attracting over a billion knowledge audience around the world. We aim to ensure these events reach the right audience.


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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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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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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