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Pre-Filled Syringes and Injectable Drug Devices
14 January - 16 January 2025
Pre-Filled Syringes and Injectable Drug Devices

FREE TO ATTEND FOR PHARMA AND BIOTECH*

Kick off 2025 and set the tone for the year at SAE Media Group's 17th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will return to London in January to unite leaders from the industry, bringing you the latest advances in the combination product drug delivery space and the chance to collaborate across a 3 day programme.

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

  • Effectively Facilitating Large Volume Delivery
  • Sustainability in the Medical Device Industry
  • Primary Drug Container Development and Biocompatability
  • Digital Health Technologies and Connected Devices


This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in January 2025!
 

FEATURED SPEAKERS

Abha Raveau-Violette

Abha Raveau-Violette

Head of Project Management of Medical Devices and Combination Products, Sandoz
Alphons  Fakler

Alphons Fakler

Director Human Factors Engineering/User Experience, Novartis
Arabe Ahmed

Arabe Ahmed

Medicinal Technical Specialist, BSI
Caroline  Zakrzewski

Caroline Zakrzewski

Senior Engineer, AstraZeneca
Cedric Gysel

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability, Johnson & Johnson
Christian Proff

Christian Proff

Senior Verification Engineer, Roche
Claus  Geiger

Claus Geiger

Global Device Leader, Sanofi
Cyril Thouseau

Cyril Thouseau

Head of Device and Packaging Vaccine LCM Portfolio, Sanofi - Global Device and Packaging Unit
Daanish Ahmed Khan

Daanish Ahmed Khan

Director, Novo Nordisk A/S
Daniel McNaught

Daniel McNaught

Head of External Manufacturing, Drug Product and Devices, UCB
Daniel McNaught

Daniel McNaught

Head of External Manufacturing, Drug Product and Devices, UCB
David Harrison

David Harrison

Business Lead, Drug Products and Devices, UCB
Estefania Dos Anjos

Estefania Dos Anjos

Senior Product Specialist, TÜV SÜD
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
Ian Thompson

Ian Thompson

Former Vice President Business Development,Delivery Systems, Ypsomed AG
Jacqueline Schendel

Jacqueline Schendel

Head of Laboratory, Boehringer Ingelheim
James Whitehead

James Whitehead

Senior Director, Devices & Digital Safety, AstraZeneca
Joel Richard

Joel Richard

Chief Development Officer, Enterome
Joseph Burt

Joseph Burt

Head of Diagnostics, Innovative Devices, MHRA
Juan Martin Carriquiry

Juan Martin Carriquiry

EU MDR & IVDR Lead, Novartis
Katharina Braun

Katharina Braun

Technical Expert Packaging & Labeling, Boehringer Ingelheim Pharma GmbH & Co. KG
Khaudeja Bano

Khaudeja Bano

Former Vice President, Combination Product Quality, Amgen
Laetitia Hourman

Laetitia Hourman

Associate Director in RA Device, Novo Nordisk
Lou Azevedo Da Silva

Lou Azevedo Da Silva

Design Engineer, Sanofi
Marc Egen

Marc Egen

Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG
Mark Hassett

Mark Hassett

Vice President of Business Development, Credence MedSystems
Michael Becker

Michael Becker

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

Michael Kuehler

Senior MD Expert, Consistency of NBOp Assessments Working Group Leader, Bayer AG, EFPIA
Niels Otterstrom Jensen

Niels Otterstrom Jensen

Head of TakeBack Program, Novo Nordisk A/S
Paul Picchione

Paul Picchione

Senior Product Assessment Expert, TÜV SÜD
Sascha Rau

Sascha Rau

Device Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Sheng Qi

Sheng Qi

Professor of Pharmaceutical Material Science and Technology, Associate Dean for Science Innovation, University of East Anglia
Steve Hoare

Steve Hoare

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

Thomas Thueer

Program Lead Autoinjectors, Haselmeier GmbH
Thomas Wejs Moeller

Thomas Wejs Moeller

Director Global Regulatory Affairs - Device, Novo Nordisk
Tiffany McIntire

Tiffany McIntire

Principal Human Factors Engineer, Roche
Xavier Donnette

Xavier Donnette

Device Program Lead, UCB

Abha Raveau-Violette

Head of Project Management of Medical Devices and Combination Products, Sandoz
Abha Raveau-Violette

Alphons Fakler

Director Human Factors Engineering/User Experience, Novartis
Alphons  Fakler

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

 

Arabe Ahmed

Medicinal Technical Specialist, BSI
Arabe Ahmed

Arabe Ahmed is a Medicinal Expert in drug–device combination products at BSI, where his role is to provide specialist pharmaceutical affairs, regulatory and strategic support to medical devices and pharmaceutical companies. Prior to joining BSI, Arabe worked for more than 10 years for GSK and Novartis in the UK, and Germany respectively in various pharmaceutical development roles. He holds a doctorate degree in drug delivery research from Julius Maximilian University of Würzburg, Germany, and masters degree in Pharmaceutical Technology form King's College London. In addition, Arabe is a UK registered pharmacist and member of the Royal Pharmaceutical Society of Great Britain.

Caroline Zakrzewski

Senior Engineer, AstraZeneca
Caroline  Zakrzewski

Cedric Gysel

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

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

Christian Proff

Senior Verification Engineer, Roche
Christian Proff

Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory) and Switzerland (Paul-Scherrer-Institut). Within Global Device and Packaging Development at F. Hoffmann - La Roche he is working in Verification Engineering since 2018 on improvements in CCI testing and development of new device test methods. He is as well an export for risk assessments and development of validation approaches in development and cGMP environments.

Claus Geiger

Global Device Leader, Sanofi
Claus  Geiger

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

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

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

Confirmed Representative

, BioPhorum
Confirmed Representative

Cyril Thouseau

Head of Device and Packaging Vaccine LCM Portfolio, Sanofi - Global Device and Packaging Unit
Cyril Thouseau

Cyril Thouseau began his career at Sisley as a chemist and incoming control manager. Since 2001, I have held various industrial roles at Sanofi, including QC Packaging Manager and QA Supplier Manager. After earning a Master in Quality and Organization, he focused on device and packaging industrialization and contributed to the creation of the critical material management organization. Following strategic initiatives at Sanofi Pasteur, he pursued an Executive MBA in International Business Development. He then joined the R&D Sanofi’s consumer healthcare unit to lead various product categories as open innovation lead After three years, he transitioned to the global procurement organization as Global Elastomer and Tubular Glass Category Director. Currently, he is the Global Head of Device and Packaging Portfolio for the Vaccine Business Unit at Sanofi, responsible for lifecycle strategies, capacity planning, and supply continuity within the new Global Device and Packaging Unit organization newly created.

Daanish Ahmed Khan

Director, Novo Nordisk A/S
Daanish Ahmed Khan

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


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

Daniel McNaught

Head of External Manufacturing, Drug Product and Devices, UCB
Daniel McNaught

Daniel McNaught

Head of External Manufacturing, Drug Product and Devices, UCB
Daniel McNaught

David Harrison

Business Lead, Drug Products and Devices, UCB
David Harrison

Estefania Dos Anjos

Senior Product Specialist, TÜV SÜD
Estefania Dos Anjos

Estefania Dos Anjos is a Senior Product Specialist in TÜV SÜD, with authorizations as Technical Documentation Assessor for MDN 1201, MDN 1202, MDN 1206, MDN 1208, MDN 1211 and MDN 1213 devices. Medicinal product Specialist for MDS 7001 (drug-device combination devices) and Product reviewer for Article 117 devices. Pharmacist with several years of experience in regulatory affairs of medical devices, pharmaceuticals, and cosmetic products in Latin America and Europe, Quality Management Systems under ISO 13485 and Good Manufacturing Practices.

Fatima Bennai-Sanfourche

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

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


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


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


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


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

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


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


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


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

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.

Ian Thompson

Former Vice President Business Development,Delivery Systems, Ypsomed AG
Ian Thompson

Jacqueline Schendel

Head of Laboratory, Boehringer Ingelheim
Jacqueline Schendel

James Whitehead

Senior Director, Devices & Digital Safety, AstraZeneca
James Whitehead

James is a Patient Safety professional with over 10 years of experience in life sciences, holding a BSc in Psychology, an MSc in Pharmacovigilance an MBA. His MBA focused on innovation within pharmacovigilance and what are the components of a successful innovation ecosystem.

The majority of James’ career has been spent in core Pharmacovigilance activities, from literature monitoring and case processing through to authoring risk management plans. In the last few years, James has been supporting the inclusion of medical devices and digital health requirements/demands into AstraZeneca Global Patient Safety organization.

 

Joel Richard

Chief Development Officer, Enterome
Joel Richard

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

Joseph Burt

Head of Diagnostics, Innovative Devices, MHRA
Joseph Burt

Juan Martin Carriquiry

EU MDR & IVDR Lead, Novartis
Juan Martin Carriquiry

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads complex compliance projects to meet the latest regulatory requirements. In this role, Juan has pioneered efforts in Combination Products in Europe by leading Notified Body Opinion submissions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest possible value.
 

Katharina Braun

Technical Expert Packaging & Labeling, Boehringer Ingelheim Pharma GmbH & Co. KG
Katharina Braun

Khaudeja Bano

Former Vice President, Combination Product Quality, Amgen
Khaudeja Bano

Laetitia Hourman

Associate Director in RA Device, Novo Nordisk
Laetitia Hourman

Laetitia is Associate Director in Regulatory Affairs for Devices at Novo Nordisk, where she leads a team of Regulatory Affairs professionals and specialists to provide regulatory strategy to development and ensure successful approvals globally.
She brings 13 years of experience from Novo Nordisk's combination device development and product supply value chain, with a total of 18 years in the medico or pharma industry, having worked in France, India, and Denmark.
Laetitia holds a Master's degree in Mechanical Engineering from the Technical University of Compiègne (France) and has completed several certifications, including a Certificate in Strategic R&D Management from INSEAD.
Laetitia is multilingual: French as mother tongue, professional proficiency in Danish and English, and everyday proficiency in Swedish.
 

Lou Azevedo Da Silva

Design Engineer, Sanofi
Lou Azevedo Da Silva

Marc Egen

Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG
Marc Egen

Marc is a polymer chemist by training and joined Boehringer Ingelheim more than 20 years ago. He was working in various positions at the interface between Development and Operations. Dealing mostly with pharmaceutical technology, manufacturing, and packaging processes, he gained experience in inhalation drug product development, solids manufacturing, launches and transfers, and solids and parenteral packaging development.

Mark Hassett

Vice President of Business Development, Credence MedSystems
Mark Hassett

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

Michael Becker

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

Michael Kuehler

Senior MD Expert, Consistency of NBOp Assessments Working Group Leader, Bayer AG, EFPIA
Michael Kuehler

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.

Paul Picchione

Senior Product Assessment Expert, TÜV SÜD
Paul Picchione

Sascha Rau

Device Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Sascha Rau

Sascha has a background in experimental physics with a Master from the University of Mainz and a PhD from the University of Heidelberg. After a brief period as postdoc at the Max Planck Institute for nuclear physics he joined Boehringer Ingelheim in 2021 as a Scientist in the Device Development group. Starting in the test method laboratory, he took over roles in various innovation projects, many related to making devices more sustainable. He is also a member of the SC Consortium’s sustainability subgroup.

Senior Representative

, MHRA
Senior Representative

Sheng Qi

Professor of Pharmaceutical Material Science and Technology, Associate Dean for Science Innovation, University of East Anglia
Sheng Qi

Sheng obtained her BEng. (Hons) in Industrial Pharmacy in 2001 (China Pharmaceutical University). After completing her PhD in 2004 (Queen’s University of Belfast) in the area of lipid based microparticulate drug delivery systems, Sheng worked as a postdoctoral scientist studying the structure and stability of amorphous polymer-drug dispersions. In 2007 Sheng joined the School of Pharmacy at UEA as a lecturer and was promoted to senior lecturer in 2013. Sheng has worked closely with leading pharmaceutical and excipient companies in the areas of pharmaceutical processing, physicochemical characterisation, and formulation development.

Sheng’s current research interests mainly focus on gaining a fundamental understanding of the behaviour of drug-polymer/lipid dispersions in solid (phase behaviour) and liquid (in biological fluids) states, and developing new approaches for stabilising supersaturated drug dispersions. By working with industrial partners as well as cross-discipline collaborators, her group is aiming to contribute to the interdisciplinary research area of enhancing drug absorption via tailoring the physical chemistry of drug formulations.

Steve Hoare

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

Thomas Thueer

Program Lead Autoinjectors, Haselmeier GmbH
Thomas Thueer

Thomas Thueer is the Program Lead at Haselmeier for the PiccoJect autoinjector. He started his career in the field of medical devices at DCA on the design of insulin pens. He then transitioned to pharma and gained substantial experience in combination product development from design input all the way to product launch as a device team leader at Roche, where he was also a founding member of the Autoinjector Technology Centre. Dr Thueer holds a Master’s degree in Mechanical Engineering, as well as a PhD in Robotics from ETH Zurich in Switzerland.

Thomas Wejs Moeller

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

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

Tiffany McIntire

Principal Human Factors Engineer, Roche
Tiffany McIntire

Torsten Kneuss

Head of Project Office Medical Devices, Bayer
Torsten Kneuss

Xavier Donnette

Device Program Lead, UCB
Xavier Donnette

Xavier Donnette is a program manager and development engineer with over 20 years of experience in the field of mechanical engineering, particularly within the medical device industry. Holding a Master’s degree in Mechanics from the prestigious École Nationale Supérieure d'Arts et Métiers (ENSAM) in France, Xavier has specialized in developing combination products and devices such as dry powder inhalers (DPI), nasal pumps, and insulin pens. His career has spanned multiple leadership roles, managing both technical and multidisciplinary teams across a variety of projects.


Xavier’s professional journey began in 2000, where he took on roles ranging from design engineer to mechanical project manager for major companies like Aptar, PSA and EADS. Over the years, his expertise in design, risk management, and compliance with industry standards has enabled him to lead complex projects from conceptualization to production, including obtaining intellectual property patents.


Currently, Xavier serves as device program lead in Switzerland for UCB, specializing in the development of Auto-injectors, On-Body Delivery Systems and other medical devices. He oversees sterility control, mechanical and electronic assessments, manages supplier relationships, and ensures adherence to standards.


In addition to his technical knowledge, Xavier is also recognized for his project management skills, having successfully led teams in international environments, including assignments in Sweden and Germany.
 

Ying Wang

Head Of Device Development Science, Pfizer
Ying Wang

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Chair's Opening Remarks

David Harrison

David Harrison, Business Lead, Drug Products and Devices, UCB

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9:10

Post market safety reporting for combination products and injectable devices

Khaudeja Bano

Khaudeja Bano, Former Vice President, Combination Product Quality, Amgen

  • How have we seen industry adapting to meet evolving regulations through effective compliance strategies
  • Current guidance for industry on post market safety reporting for combination products
  • Case study examples for effective approaches to efficiently maintain global reporting compliance for combination products and injectable devices
  • Looking to the future how can we expect the global regulatory landscape to evolve for combination product reporting and recommendation to be best prepared
     
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    9:50

    Impact of Medical Device Regulation on Drug-Device Combinations: A Current Overview

    Torsten Kneuss

    Torsten Kneuss, Head of Project Office Medical Devices, Bayer

  • Introduction to the MDR and Its Applicability to Drug-Device Combinations
  • Applicability of Importer/Distributor Obligations for Co-Packaged Drug-Device Combinations
  • Labelling and Other Considerations for Co-Packaged Devices
  • Current Challenges and Practical Guidance for Compliance

     

  • clock

    10:30

    Morning Break

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    11:00

    Advisory Board Fireside Chat: Navigating Device Selection, Bridging, Regulatory approval for Commercial Success and Upcoming Changes in the Field

  • Selecting Investigational Devices: Key factors to consider when choosing delivery devices during clinical trials in early development, while ensuring flexibility for future commercialisation
  • Bridging strategy for commercial products: Strategies to effectively transition from clinical presentations to commercial presentations, addressing regulatory expectations
  • What’s new in regulatory and technical: FDA’s draft ‘Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products’ guidance published in June 2024 and its impact on device development
  • Reviewing best practices for commercial launch
     
  • David Harrison

    David Harrison, Business Lead, Drug Products and Devices, UCB

    Khaudeja Bano

    Khaudeja Bano, Former Vice President, Combination Product Quality, Amgen

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

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

    Abha Raveau-Violette

    Abha Raveau-Violette, Head of Project Management of Medical Devices and Combination Products, Sandoz

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    11:40

    Leveraging Market Feedback for PFS Design improvement and Enhanced Patient Experience

    Lou Azevedo Da Silva

    Lou Azevedo Da Silva, Design Engineer, Sanofi

  • Navigating Patient Experience: Explore how technical parameter drifts can significantly impact patient experience
  • User-Centric approach: Uncover the power of user feedback in refining device experiences. By actively listening to users, we can truly enhance their journey and foster trust
  • Holistic collaboration: Discover the great value of a proactive initiative that brings together a multidisciplinary team
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    12:20

    Networking Lunch

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    13:20

    Design verification, control strategy and system reliability for combination product development

    Ying Wang

    Ying Wang, Head Of Device Development Science, Pfizer

  • Exploring the key elements of demonstrating system
  • reliability for combination product
  • Design verification/stability shelf life
  • Manufacture process control strategy
  • Statistical considerations: probability content vs. reliability
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    14:00

    Navigating Challenges in Injection Device Regulatory Framework: Current state of play in the EU

  • Important recent regulatory developments and challenges in the EU
  • Status of the EU MDR implementation for drug-device combinations
  • Case study: Notified Body Opinion under the EU MDR for a Prefilled Syringe
  • Practical advice: How to improve your chances of obtaining a Notified Body Opinion
  • Juan Martin Carriquiry, EU MDR & IVDR Lead, Novartis

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    14:40

    Afternoon Break

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    15:10

    Overcoming Regulatory Hurdles to Accelerate PFS Development for Fast to Clinic and Market Entry

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

  • Exploring industry experiences
  • Approaches for mitigating challenges
  • Improving development efficiency for an accelerated product development
  • clock

    15:10

    Designing for Manufacturability

  • Considering manufacturability in design, and approaches and considerations for enabling scalability
  • Effective external stakeholder management for parenteral devices
  • David Harrison

    David Harrison, Business Lead, Drug Products and Devices, UCB

    Daniel McNaught

    Daniel McNaught, Head of External Manufacturing, Drug Product and Devices, UCB

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    15:10

    As innovation in industry accelerates complex products are being designed and developed, how do members of the industry and various regulatory agencies keep up?

    Khaudeja Bano

    Khaudeja Bano, Former Vice President, Combination Product Quality, Amgen

  • Exploring industry experiences
  • Approaches for mitigating challenges
  • clock

    15:10

    Understanding drug delivery needs across research and early development portfolios

    Joel Richard, Chief Development Officer, Enterome

  • Reviewing delivery needs early in drug development – approaches and key considerations
  • Identifying novel technologies to facilitate delivery
  • clock

    16:40

    Chair’s Closing Remarks and Close of Pre-Conference Focus Day

    David Harrison

    David Harrison, Business Lead, Drug Products and Devices, UCB

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    8:00

    Registration & Coffee

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    8:20

    Chair's Opening Remarks

    Abha Raveau-Violette

    Abha Raveau-Violette, Head of Project Management of Medical Devices and Combination Products, Sandoz

    clock

    8:30

    Recent trends in the market for self-injection: Diabesity, large volume injections and sustainability

    Ian Thompson

    Ian Thompson, Former Vice President Business Development,Delivery Systems, Ypsomed AG

  • Obesity pandemic and impact on demand for drug containers and self-injection devices
  • Emergence of large volume injections for higher antibody payloads
  • Sustainability and its impact on future device needs
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    9:00

    Previewing the upcoming new UK Medical DevicesRegulations 2025

    Senior Representative

    Senior Representative, , MHRA

  • Preview of key changes put forward
  • Building sustainability by design
  • clock

    9:30

    PANEL DISCUSSION: Accelerating Drug-Device Combination Product Development with AI

  • Leveraging AI to streamline and speed up drug-device combination product development
  • Securing and Integrating AI: strategies for safely incorporating AI technologies into healthcare systems
  • Measures for ensuring patient safety and ethical AI application
  • Future Outlook: Predictions on AI-driven advancements and regulatory trends in drug-device development
  • Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

    Torsten Kneuss

    Torsten Kneuss, Head of Project Office Medical Devices, Bayer

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    10:00

    Session Reserved for Lead Sponsor

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    10:30

    Morning Coffee

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    11:00

    Session Reserved for Althena Medical

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    11:30

    Human Factors Pipeline Strategy

    Tiffany McIntire

    Tiffany McIntire, Principal Human Factors Engineer, Roche

  • Strategies and approaches to enable efficient human factors work
  • Leveraging human factors data and considerations for platforms
  • Reviewing disease states and patient populations
  • Updates in ISO standard(s) and FDA expectations in human factors testing
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    12:30

    Three years’ experience with Article 117 MDR - industry perspective

    Michael Kuehler

    Michael Kuehler, Senior MD Expert, Consistency of NBOp Assessments Working Group Leader, Bayer AG, EFPIA

  • Steps needed for a Notifi ed Body Opinion
  • Stakeholder Experiences and Challenges
  • Learning & best practices related to compliance with Article 117 MDR
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    13:00

    Networking Lunch

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    14:00

    Chair's Opening Remarks

    Claus Geiger, Global Device Leader, Sanofi

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    14:10

    Advancements and Latest Trends in Large Volume Drug Delivery

    Claus Geiger, Global Device Leader, Sanofi

  • Exploring the latest advancements in devices designed for large volume injections, focusing on their capabilities to improve therapies and enhance patient comfort and adherence
  • Discussing the technical and regulatory challenges associated with large volume drug delivery, and how these challenges can be overcome to ensure safety and efficacy
  • Reviewing successful case studies of large volume drug delivery in various therapeutic areas, highlighting the impact on treatment outcomes and patient quality of life
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    14:40

    Session Reserved for Nemera

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    15:10

    Panel Discussion: Balancing the Patient Journey with High-Volume Auto injector Production

  • Exploring developments in high volume autoinjector production
  • Effective approaches to balance decisions in development between cost of goods, patient experience, and the requirements of high-volume production lines during the development stages of autoinjectors
  • Managing production costs effectively without compromising device quality, reliability and patient centricity
  • Innovative strategies to prioritise patient needs and experience in the design and large-scale manufacturing of autoinjectors, ensuring usability and adherence
  • Tiffany McIntire

    Tiffany McIntire, Principal Human Factors Engineer, Roche

    Ian Thompson

    Ian Thompson, Former Vice President Business Development,Delivery Systems, Ypsomed AG

    Claus Geiger, Global Device Leader, Sanofi

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    15:40

    Afternoon Break

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    16:40

    Evaluation of different on-body injectors for biologicals

    Jacqueline Schendel

    Jacqueline Schendel, Head of Laboratory, Boehringer Ingelheim

  • Essential performance requirements
  • Characterization of the siliconization
  • Particulate matters
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    17:10

    Progressing On-body Device Development: Opportunities and Challenges

  • Why are there such a limited number of on body injectors on the market?
  • The challenges: from design and manufacturing to final approval
  • Maximising wearables potential through connectivity
  • Post-market supply – managing commercial supply of components, and potential need for a design change
  • Xavier Donnette , Device Program Lead, UCB

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    17:40

    Chair’s Closing Remarks and Close of Day One

    Claus Geiger, Global Device Leader, Sanofi

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    14:00

    Chair's Opening Remarks

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

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    14:10

    Sustainability in the new UK Med Dev Regs 2025

    Joseph Burt

    Joseph Burt, Head of Diagnostics, Innovative Devices, MHRA

  • Current agency position on innovative devices
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    14:40

    Polymers: A Case Study in Sustainable Material Solutions for Drug Delivery Devices

    Thomas Thueer, Program Lead Autoinjectors, Haselmeier GmbH

  • Overview of how drug delivery devices impact sustainability targets
  • Sources of emissions in plastics manufacturing
  • Mechanically recycled, biobased, mass balanced, sustainable feedstocks: What do they all mean?
  • Smart material selection for a more sustainable autoinjector
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    15:10

    An Update: ReMed™ Take Back Scheme

    Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk A/S

  • Expansion of the injection pen take back program
  • Successful collaboration with partners across the value chain
  • Sharing data and information – quantifying the impact
  • Next steps to move further towards circular for zero
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    15:40

    Afternoon Break

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    16:10

    Solutions for Emerging Challenges to Drug Delivery

    Mark Hassett, Vice President of Business Development, Credence MedSystems

  • Delivery of medications is moving from formal healthcare settings to the home
  • Injection volume ranges are broadening and viscosities are increasing
  • Solutions and suspensions risk needle clogging
  • Solutions are requiring reconstitution at the time of use
  • What solutions are available to address these challenges?
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    16:40

    Implementing Sustainable Practices in Device Development

    Sascha Rau, Device Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG

  • Processes to implement Eco-Design Criteria into Development processes
  • Biobased materials, reusable devices, take-back schemes, what makes sense and when?
  • Benchmarking and alignment in consortia
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    17:10

    Towards a circular future in pharma

    Cedric Gysel

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

  • Partnerships and policies
  • Standards
  • Use cases
  • Current standing and future plans
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    17:40

    Chair's Closing Remarks and Close of Day One

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

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    8:15

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

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

    Cyril Thouseau, Head of Device and Packaging Vaccine LCM Portfolio, Sanofi - Global Device and Packaging Unit

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    9:30

    What is clinical contribution to device development? One Patient Safety professionals’ view on holistic input

    James Whitehead, Senior Director, Devices & Digital Safety, AstraZeneca

  • Discuss what “clinical” means
  • Review clinical contribution to device development
  • Consider one model for central clinical contribution to device development and explore others
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    10:00

    Session Reserved for Sponsor

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    10:30

    Morning Coffee

    clock

    11:00

    How to collect Post-Market-Clinical Follow-up Data (PMCF)

    Heinrich Martens, Vice President Regulatory Affairs, Fresenius Kabi

  • Case study on how to collect PMCF Data
  • Data sources and data collection
  • How to justify the collected data: Statistically approach
  • Evaluation and integration within the PMS process
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    11:30

    Navigating Essential Drug Delivery Outputs (EDDO) in Combination Product Development

    Laetitia Hourman, Associate Director in RA Device, Novo Nordisk

  • Examining the clarity and direction in EDDO Guidance and industry response
  • Addressing regulatory challenges related to EDDO integration and the need for global harmonization
     
  • clock

    12:00

    Shaping the Design Space: Unboxing the Potential of Packaging Forces

  • Introduction to the concept of handling forces and our methodology for measuring them
  • Presentation of our key findings and insights from the measurement results
  • Explanation of how these results define our design space
  • Discussion about the potential and limitations of the design space
  • Michael Becker

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

    Katharina Braun

    Katharina Braun, Technical Expert Packaging & Labeling, Boehringer Ingelheim Pharma GmbH & Co. KG

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    12:30

    Panel Discussion: Navigating the Regulatory Landscape for Pre-Filled Syringes and Injectable Drug Devices

  • Key hurdles faced during multi-market launches, with industry examples and experiences highlighting best practices
  • Impact of newly released guidance, such as the EDDO, on the device development process and approaches for overcoming associated challenges and to ensure continued development and innovation
  • Enhancing Industry-Regulatory Collaboration: Discuss how regulatory bodies and the industry can better align to streamline processes, improve communication, and facilitate smoother regulatory engagements
  • Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

    Arabe Ahmed, Medicinal Technical Specialist, BSI

    Heinrich Martens, Vice President Regulatory Affairs, Fresenius Kabi

    Michael Kuehler

    Michael Kuehler, Senior MD Expert, Consistency of NBOp Assessments Working Group Leader, Bayer AG, EFPIA

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    13:00

    Networking Lunch

    clock

    14:00

    Chair's Opening Remarks

    Marc Egen, Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG

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    14:40

    Session Reserved for Cormica

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    15:10

    Notified Bodies’ Perspectives: Injectable Device Development

    Estefania Dos Anjos, Senior Product Specialist, TÜV SÜD

  • Outlining key primary packaging requirements
  • What is needed for a successful submission and NB opinion?
  • Challenges in lifecycle management of combination products
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    15:40

    Afternoon Break

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    16:10

    Session Reserved for ZEON

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    16:40

    Comparing Container Closure Integrity Test Methods

    Christian Proff, Senior Verification Engineer, Roche

  • Insight into helium leak testing and carbon dioxide-based headspace analysis to detect leaks in packaging
  • Demonstrating result comparison between the methods
  • Advantages and disadvantages of both techniques
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    17:10

    Determining Biocompatibility During Device Product Lifecyle

    Confirmed Representative

    Confirmed Representative, , BioPhorum

  • Biocompatibility Testing Across the Product Lifecycle
  • Risk Assessment Strategies and Requirements
  • Device Categorization for Cumulative Use
  • GSPR and EU MDR
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    17:40

    Long acting injectable – formulation technologies and trends

    Sheng Qi, Professor of Pharmaceutical Material Science and Technology, Associate Dean for Science Innovation, University of East Anglia

  • What is the added value of long acting injectables
  • What formulation technologies are used for long acting injectables
  • What are the trends in the fi eld from a formulation perspective
  • What requirements does this formulation have to the device
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    18:10

    Chair’s Closing Remarks and Closing of Day Two

    Marc Egen, Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG

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    14:00

    Chair's Opening Remarks

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

    clock

    14:10

    Integrating AI and machine learning in connected medical devices

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

  • Discuss the role of AI in enhancing device functionality and personalized medicine
  • Strategies for ensuring seamless integration of AI into medical device QMS
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    14:40

    Session Reserved for DCA Design

    clock

    15:10

    Panel Discussion: Creating a Connected Ecosystem: Utilising Connected Devices in Clinical and Commercial Settings

  • Complexities and strategies for the building and development of connected ecosystems
  • Optimising components in a connected ecosystem to enhance patient experience and adherence
  • How do we make these technologies impactful in clinical trials and financially viable for post market real world evidence studies
  • Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

    James Whitehead, Senior Director, Devices & Digital Safety, AstraZeneca

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    15:40

    Afternoon Break

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    16:10

    Session Reserved for Gerresheimer

    clock

    16:40

    Navigating Connected Device and Combination Product Regulatory Challenges

    Arabe Ahmed, Medicinal Technical Specialist, BSI

  • Discussion of the impact of MDR and evolving regulations on connected devices and drug combination products
  • Delving into manufacturer responsibilities
  • Efficiently managing software changes and product updates
  • Approaches for successful fulfilment and evidence of the General Safety and Performance Requirements (GSPRs)
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    17:10

    Conformity assessment challenges for digital health and connected medical devices

    Paul Picchione

    Paul Picchione, Senior Product Assessment Expert, TÜV SÜD

  • Software life cycle aspects and connected medical devices
  • Cybersecurity: How to ensure security and privacy for active medical devices
  • Implementing artificial intelligence in medical devices
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    17:40

    The Value of Digital Healthcare for Drug Delivery Devices

    Confirmed Representative

    Confirmed Representative, , BioPhorum

  • What benefits can be gained from digital? For the patients, the payers and the industry
  • Clarifying the meaning of value in the drug delivery space
  • Overcoming challenges of digital healthcare within the medical device space
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    18:10

    Chair’s Closing Remarks and Closing of Day Two

    Daanish Ahmed Khan, Director, Novo Nordisk A/S


    Head of Project Management of Medical Devices and Combination Products
    Sandoz
    Director Human Factors Engineering/User Experience
    Novartis
    Medicinal Technical Specialist
    BSI
    Senior Engineer
    AstraZeneca
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Senior Verification Engineer
    Roche
    Global Device Leader
    Sanofi
    BioPhorum
    Head of Device and Packaging Vaccine LCM Portfolio
    Sanofi - Global Device and Packaging Unit
    Director
    Novo Nordisk A/S
    Head of External Manufacturing, Drug Product and Devices
    UCB
    Head of External Manufacturing, Drug Product and Devices
    UCB
    Business Lead, Drug Products and Devices
    UCB
    Senior Product Specialist
    TÜV SÜD
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Vice President Regulatory Affairs
    Fresenius Kabi
    Former Vice President Business Development,Delivery Systems
    Ypsomed AG
    Head of Laboratory
    Boehringer Ingelheim
    Senior Director, Devices & Digital Safety
    AstraZeneca
    Chief Development Officer
    Enterome
    Head of Diagnostics, Innovative Devices
    MHRA
    EU MDR & IVDR Lead
    Novartis
    Technical Expert Packaging & Labeling
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Former Vice President, Combination Product Quality
    Amgen
    Associate Director in RA Device
    Novo Nordisk
    Design Engineer
    Sanofi
    Head of Primary Packaging & Process Development
    Boehringer Ingelheim Pharma Gmbh & Co. KG
    Vice President of Business Development
    Credence MedSystems
    Packaging Engineer
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Senior MD Expert, Consistency of NBOp Assessments Working Group Leader
    Bayer AG, EFPIA
    Head of TakeBack Program
    Novo Nordisk A/S
    Senior Product Assessment Expert
    TÜV SÜD
    Device Engineer
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Professor of Pharmaceutical Material Science and Technology, Associate Dean for Science Innovation
    University of East Anglia
    Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission
    Medicines and Healthcare products Regulatory Agency (MHRA)
    Program Lead Autoinjectors
    Haselmeier GmbH
    Director Global Regulatory Affairs - Device
    Novo Nordisk
    Principal Human Factors Engineer
    Roche
    Head of Project Office Medical Devices
    Bayer
    Device Program Lead
    UCB
    Head Of Device Development Science
    Pfizer

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    VENUE

    Leonardo Royal London St Paul's Hotel

    United Kingdom

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Interview - Michael Kuehler

    Download

    Advisory Board Letter

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    Past Attendee List

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    Past Presentation - Cinzia Rotella

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    Past Presentation - Anna Sawicki

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    Past Presentation - Louise Place

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    Past Presentation - Hans Jensen

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    Sponsors and Exhibitors


    Althena Medical

    Gold Sponsor
    http://www.althenamedica.it/

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

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

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

    100% Made in Italy!



    Cambridge Consultants

    Gold Sponsor
    https://www.cambridgeconsultants.com/home


    Sponsors


    CORMICA LTD

    Sponsors
    https://www.cormica.com/

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



    Credence MedSystems

    Sponsors
    http://www.credencemed.com

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


    DCA

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

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

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

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

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

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



    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the 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).


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

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



    Nemera

    Sponsors
    http://www.nemera.net

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



    ZEON Europe GmbH

    Sponsors
    http://www.zeon.eu/cop-copf-zeonex-zeonor-zeonorfilm.html

    Zeon Europe GmbH is the European marketing/sales organisation of Zeon Corporation / Japan. As part of specialty materials operations Zeon produces Cyclo-Olefin Polymers (COP) under the tradenames ZEONEX® and ZEONOR®. The balance of outstanding water barrier properties in combination with high purity, excellent chemical resistance, high transparency and low interaction with drugs, put ZEONEX® and ZEONOR® as a perfect alternative to glass or other plastics solutions for pharmaceutical and biopharmaceutical containers - such as Pre-filled syringes, cartridges and vials.

    Exhibitors


    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.



    Kymanox

    Exhibitors
    https://www.kymanox.com/

    Kymanox® is your life science solutions partner with a diverse team of experts who know how to connect the dots and make sure you have the right end-to-end solutions for your modern medicine development & commercialization challenges.

    We are experts in providing our clients in the combination products, biologics, pharmaceutical, and medical device industries with support from early development to post-market. We help bring products from bench to patient.



    MTD ENGINEERING

    Exhibitors
    http://mtdglobal.com/mtd-engineering/

    MTD ENGINEERING Established in 2020, MTD Engineering operates as a centre for innovation and development, with the goal of driving progress in research and development. The hub generates new ideas, patents and solutions, through rigorous testing and rapid in-house development. It is, therefore, instrumental in crafting pioneering designs that feed into MTD’s product pipeline and functions as a reliable collaborator across various industries, supporting them through every phase of new product development, by: • Crafting new and highly competitive concepts and designs aimed at reducing costs while enhancing performance. • Providing consultancy services covering a range of topics, including tool and machine construction and maintenance, as well as establishing and fine-tuning production processes. • Producing components or complete products tailored to fulfil the specific requirements of partner entities. Harnessing its vast experience, know-how, and infrastructural resources, MTD Engineering creates state-of-the-art medical devices that improve daily living, merging small-scale technological solutions with wider applications. MTD Engineering’s team brings its specialized skills and knowledge of pivotal technologies, like steel processing, fabric processing, sterilization, automation, and moulding, to a range of other sectors such as veterinary medicine, watchmaking, home appliances, cosmetics, and laboratory. MTD Engineering is a division of MTD Group, a leading med-tech group, designing, manufacturing and providing globally a full range of medical sharps and medical devices for home and professional care, based on the experience and competence of 1400+ employees, our widespread presence around the world, 4 production plants in Europe.


    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.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.

    Media Partners


    On Drug Delivery

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

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

    Media Partners


    The Medicine Maker

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

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


    pharmaphorum

    Supporting 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


    Pharma Journalist

    Supporting 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.

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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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