Programme

Note: this programme is subject to change.

MONDAY, 19 NOVEMBER

 

18.30 – 19.30
Welcome drinks reception

The welcome drinks reception will be held at Pebble Wood Corner, the restaurant on the first floor of the Radisson Hotel. We would appreciate confirmation of your intention to attend by emailing us at meetings@topra.org.


TUESDAY, 20 NOVEMBER

 

 
TOPRA/RAPS Inter-regulatory and Stakeholder Workshop
Addressing the Impact of the EU Medical Device Regulation on ‘Combination’ Products
 
8.30  Registration opens 
8.45  Welcome

8.50


Introduction
- Aim of the meeting: to confirm interpretations and contribute towards consistent approach across stakeholder groups

Speakers:
- Gert Bos, Executive Director and Partner, Qserve Group
- Janine Jamieson, EU Editor, IPQ Publications
- Neil Armstrong, CEO, MeddiQuest Regulatory Affairs Ltd

 
Legislative Background and State of Play Guidance & Interpretation
 
9.00
Background MDR on drug-device combination products
- Rule 14, Rule 18, Rule 21, Article 117
- Devices incorporating ancillary medicinal substances/human blood products/cells and tissues
- Transition and implementation perspectives

Speaker:
- Vincent Houdry, Administrateur Dispositifs Médicaux, DG GROW, EU Commission
 
9.10  
Background amending 2001/83/EC on device-drug combination products
- Article 117
- working with DG Grow
- Transition and implementation perspectives

Speaker:
- Dagmar Stará, Policy Officer, DG SANTE, EU Commission

9.20 


Medicines Competent Authority perspective
- History
- Challenges
- Plan for transitioning historic MHRA consultations

Speaker:
- Elizabeth Baker, Group Manager - Licensing Division, Medicines and Healthcare products Regulatory Agency (MHRA) - UK
 
9.30

EMA perspective
- NB consultations
- cATMPs 
- Transition and Article 117 implementation perspectives

Speaker:
- Armin Ritzhaupt, Regulatory Affairs, European Medicines Agency (EMA) 

9.40
QWP/BWP concept paper on DDCs and MAAs
- progress and working with Notified Bodies
- complex implementation, constraints
- roles and responsibilities of Notified Bodies and Competent Authorities

Speaker:
- Abigail Moran, Senior Pharmaceutical Assessor, MHRA - UK and Rapporteur QMP/BWP
 
9.50 
CAMD perspective
- CAMD/HMA cooperation
- EMA/CAT-NB collaboration group for cATMPs
- Ensuring consistency of approach - guidance

Speaker:
- To be announced
 
10.00 
Panel discussion
Discussion and questions focusing on responding to previous presentations and discussion paper questions
 
10.30   
Coffee break
 


Devices Incorporating Ancillary Medicinal Products

11.00

Session and speaker introduction

Speaker:
- Gert Bos, Executive Director and Partner, Qserve Group

 
11.10
Notified Body perspective

Speaker:
- Theresa Jeary, Head of Notified Body – Medical Devices, LRQA
 

11.20 
Medicines Competent Authority perspective

Speaker:
- Waldo Weijers, Senior Advisor / Coordinator - Consultation Procedures Medical Devices, Medicines Evaluation Board (Netherlands)
 
11.30   
Industry perspective

Speaker:
- Oliver Bisazza, Director, Regulations and Industrial Policy, MedTech Europe
 

11.40   
Industry example scenarios

Speaker:
- To be announced
 
11.50 
Panel discussion
Discussion and questions focusing on responding to previous presentations and toward potential directions and solutions

Participants:
- Jonathan Sutch, Technical Expert, BSI (discussion leader)
Guy Buijzen, Regulatory Affairs / Senior Project Manager, DEKRA Certification, and President, TEAM-NB
 
12.30 
Lunch
 

Medicinal Products Incorporating Medical Devices 
 
13.30  
Session and speakers introduction

Speaker:
- Janine Jamieson, EU Editor, IPQ Publications

13.40 
Medicinal Products Competent Authority perspective

Speaker:
- Ann Jans, Quality Assessor - MedDev, Federal Agency for Medicines and Health Products - FAMHP (Belgium)
 
13.50  
Notified Body perspective

Speaker:
Guy Buijzen, Regulatory Affairs / Senior Project Manager, DEKRA Certification, and President, TEAM-NB

14.00   
Industry perspective

Speaker:
- Serge Mathonet, Global Regulatory Affairs Biologics Center CMC Interface, Sanofi-Aventis, and European Biopharmaceutical Enterprises' Biomanufacturing DDC Group
 

14.10 
Industry example scenarios

Speaker:
- Mark Chipperfield, Principal Consultant and Director, Corvus Device Ltd
 
14.20 
Panel discussion
Discussion and questions focusing on responding to previous presentations and toward potential directions and solutions

Participants:
- Tim Chesworth, Sr Dir Regulatory Affairs - Medical Devices & Combination Products, AstraZeneca (discussion leader)
- Vikas Jaitely, Senior Manager – CMC Regulatory, Merck Group
- Maren von Fritschen, Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)


15.30   
Tea break
 

 
Stakeholder Discussion and Conclusions
 
 
16.00   
Summary of key points
 
16.10 
All speaker panel debate
 

16.50 
Wrap-up
 
 17.00
Close