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2024 Combination Products in the EU | 30-31 January 2024


AGENDA




AGENDA



DAY ONE: TUESDAY, 30 JANUARY 2024  

08:15
Registration and Welcome Coffee
09:00
Welcome Remarks and Introduction
DIA & RAPS 09:20
Opening Plenary─Combination Products in Europe: Gaining Traction?

The panel will discuss the challenges that the MDR brings specifically for
combination products, whether this is the transition from MDD to MDR, the
reclassification of a legacy device as a combination product under MDR, and the
challenges of Article 117. Panel members will bring their perspectives on these
and on how to help keep innovative combination products in Europe.

Session Chairs:

 * Gert Bos, Executive Director & Partner, CEO Qserve China, Qserve Group B.V.
 * Sophie Tabutin, EMEA Regulatory Affairs Leader, W.L. Gore

Speakers:

 * Flora Giorgio, Head of Unit, D3Medical Devices, DG SANTE, European Commission
 * Lars Hyveled-Nielsen, Regulatory Project Director, Zealand Pharma
 * Björn Eriksson, Director General, Swedish Medical Products Agency
 * Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines
   Agency
 * Notified Body representative (coming soon)
 * Pharmaceutical Industry representative (coming soon)

10:40
Coffee Break
11:10
Development of Medicinal Products with Co-Packaged Devices/Cross-Referenced
Devices: Challenges and Opportunities

This session will explore the development of medicinal products with co-packaged
devices/cross-referenced devices, its challenges and the opportunities that
arise with it. The session will start with scene-setting presentations that
serve as a foundation for parallel roundtable discussions, encouraging in-depth
collaborative discussions in smaller groups focused on solutions and strategies.

Session Chair:

 * Andreas Emmendoerffer, Regulatory Group Director – Device and Combination
   Products, Roche

Scene Setting:

 * Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines
   Agency
 * Isabelle Mingam, Associate Director, Global Regulatory Affairs CMC and
   Medical Devices, UCB

Panel Discussion with additional representatives from:

(this panel will be invited to comment on the conclusions from the roundtable
exercise)

 * Notified Bodies (coming soon)

13:00
Lunch Break
13:15
(Sponsored Presentation) Practical Applications of Article 117 MDR: When Your
Primary Packaging Might be a Medical Device

The presentation focuses on the medical device parts of combination products,
specifically components like spray bottles, dropper bottles and syringes — which
can be considered as a medical device or just a container closure system,
depending on the circumstances.

Speaker:

 * Dr. Cora Hallas, Medical Science & Affairs Manager (Medicinal
   Products/Medical Devices), Cora Hallas, Medical Science & Affairs Manager
   (Medicinal Products/Medical Devices), Dr Ebeling & Assoc. GmbH

14:00
Notified Body Opinion (NBOp) Article 117 of the MDR: Challenges and Possible
Ways Forward

Published by the European Commission under the Medical Devices Regulation in
2017 and formally applied in 2021, Article 117 has added a new dynamic to the
relationship between companies and Notified Bodies. Though it provides an
important layer of protection, implementation has not been without
controversy—leading to longer approval times, and increased costs for smaller
businesses. This session will look to provide an overview of the challenges new
innovations are facing due to cumbersome regulations, and explore how Notified
Bodies, policymakers and industry can collaborate to provide a well-regulated
environment which encourages progress.

Session Chair:

 * Thomas Wejs Møller, Director Global Regulatory Affairs - Devices, Novo
   Nordisk

Speakers:

 * Thomas Wejs Møller, Director Global Regulatory Affairs - Devices, Novo
   Nordisk
 * Paul Piscoi, Scientific Policy Officer, European Commission
 * Jonathan Sutch, Principal Medicinal Technical Specialist, BSI, UK
 * Tracey Burr, Executive Director, CMC Regulatory Affairs, Ionis
   Pharmaceuticals, Inc.
 * Pascal Venneugues, Principal Scientist, European Medicines Agency

15:30
Coffee Break
16:00
Impact of the New EU General Pharma Legislation on Combination Products

Continuing the previous discussion, this session will explore the potential
impact of the new EU General Pharma Legislation on Combination Products focusing
on lifecycle management, particularly on limitations/challenges of the existing
variations guidelines vs. variations revision/regulation with the new draft of
the GPL in mind.

Session Chair:

 * Thomas Wejs Møller, Director Global Regulatory Affairs - Devices, Novo
   Nordisk

Speakers:

 * Amanda Matthews, Senior Director, Regulatory CMC for Combination Products &
   Medical Devices, Pfizer
 * Lilia Luchianov, Policy Officer DG Sante, European Commission

Panel Discussion and Q&A with the additional participation of:

 * All speakers and panellists from the previous session
 * Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines
   Agency

17:00
Wrap-up and Highlights of Day 1

DIA & RAPS

17:15
Networking Reception
18:30
End of Day 1


DAY TWO: WEDNESDAY, 31 JANUARY 2024  

08:30
Registration and Welcome Coffee
09:00
Welcome Remarks and Introduction

DIA & RAPS

09:10
Medical Devices in Medicinal Product Clinical Trials

Use of Medical Devices (both hardware and software) are becoming an increasingly
prominent feature of medicinal product clinical trials. These are exciting
opportunities to develop innovative therapies efficiently and safely to enhance
patient outcomes. Progressing these opportunities raises a number of regulatory
challenges as these combined studies bring together requirements in the CTR and
MDR, in addition to those of individual Member States. This session aims to
provide insight into these challenges and provide an opportunity to identify
ways forward to address them.

Session Chair:

 * Tim Chesworth, Senior Director Regulatory Affairs, AstraZeneca

Speakers:

 * Ilona Reischl, CAT Chair & Biologics Quality Assessor, AGES, Austria
 * Olga Tkachenko, Policy Officer, DG Sante Unit D3 – Medical Devices, European
   Commission
 * Isabelle Clamou, Policy Officer, DG Sante Unit D2 – Medicinal Products,
   European Commission
 * Ruth Foster, Director Regulatory Affairs Medical Device and Digital Health
   EMEA, MSD
 * Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance,
   European Medicines Agency

10:30
Coffee Break
11:00
MDR Rule 14 – Current Challenges for Medical Device Manufacturers in Meeting MDR
Re-Consultation Requirements and Future Considerations for the Management of
Post Opinion Changes

In this session, we will look at the differing perspectives (CA vs NB vs
Manufacturer) in the requirements for the medicines agency consultation and
share some of the major challenges that Device Manufacturers face when trying to
meet Medicinal product expectations. The session shall also look to the Post
Opinion Challenges faced by Manufacturers and Notified Bodies where changes are
made to the Medical Device and detail examples/case studies where device changes
do not impact on the ancillary medicinal substance.

The session will start with scene-setting presentations that serve as a
foundation for parallel roundtable discussions, encouraging in-depth
collaborative discussions in smaller groups focused on solutions and strategies.

Session Chair:

 * Theresa Jeary, Technical Specialist & Scheme Manager, BSI

Scene Setting:

 * Theresa Jeary, Technical Specialist & Scheme Manager, BSI
 * Janine Jamieson, European Editor, International Pharmaceutical Quality (IPQ)
 * Sam Greenhalgh, Regulatory Affairs Director, Smith & Nephew

Panel Discussion:

(this panel will be invited to comment on the conclusions from the roundtable
exercise)

12:45
Lunch Break
13:45
Closing Plenary
 

Combination Products: Building Blocks for Future Patient Care

 * Gert Bos, Executive Director & Partner, CEO Qserve China, Qserve Group B.V.

 Combination Products: Towards Harmonised Interpretations

 * Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD

Session Chairs:

 * Tim Chesworth, Senior Director Regulatory Affairs, AstraZeneca
 * Anja Wiersma, CEO and Senior Consultant, mi-CE consultancy

Panel Discussion and Q&A with the additional participation of:

 * Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines
   Agency
 * Notified Body representatives (coming soon)
 * SME representatives (coming soon)
 * Ilona Reischl, CAT Chair & Biologics Quality Assessor, AGES, Austria

15:10
Wrap-up, Highlights of the Summit and Closing

DIA & RAPS

15:30
Combination Products in the EU Summit 2024 Concludes