TOPRA In France Meeting - Face to Face

TOPRA In France Meeting - Face to Face
TOPRA In France invites members to this face to face meeting in Paris, where three key speakers will be giving presentations on risk assessment in veterinary medical products, CGT and ATMP developments and replacing ATU.





Date: Thursday 23 May 2024
Time: 9am-3pm BST (GMT +1) / 10am-4pm (CEST)
Venue: ICON Nanterre, 64 Avenue des Champs Pierreux, Paris – salle Ile de La Réunion 2.

Please note:  this is a face-to-face meeting.  For the online option, please click here.   Numbers limited to 20 individuals for this meeting.


AGENDA

10am-11am:  Welcome

11am-12pm: Challenges & Perspectives of the Environmental Risk Assessment in the Veterinary Medicinal Products – Corinne Philippe

The Environmental Rik Assessment (ERA) is a core part of the veterinary regulatory dossier for pharmaceuticals but also recombinant vaccines. Focusing mainly on the pharmaceuticals, the presentation will cover the history of the implementation of the ERA, how it evolved, the current state, stakes and challenges, and discuss some perspectives on the future evolution of the regulatory framework of the heavily debated topic.

1pm-2pm: Interconnections between regulatory CMC and clinical for CGT/ATMP developments + GMO ERA – Gabriel Bohl

Clinical and CMC teams interconnections must be strong during clinical development of complex biological molecules, including Cell Gene Therapies and ATMPs. A general presentation  on why and how CMC and clinical teams should be connected will be provided with case studies. The webinar will end with a Questions and Answers session.

2pm-3pm: Compassionate use and early access – ANSM (replacing ATU-RTU) – Katleen Abergel

The article number 78 of the LFSS (2021) modified the ATU/RTU systems in France. This topic aims to ensuring the continuity of the early access to promote drug innovation in France. The presentation will cover the eligibility criteria, the implementation, the funding and the follow-up of the early access in France. It will end with a focus on rare disease.

3pm-4 pm – General discussions, AOB


SPEAKERS

Corinne Philippe is leading the global Regulatory Intelligence, Policy and Communications team in Boehringer Ingelheim Animal Health and she is based in Lyon, France.   Corinne is a Doctor of Veterinary Medicine, and holds a master’s degree in Regulatory Affairs (TOPRA MSc Reg Aff) and has 20+ years of experience in the animal health pharmaceutical industry, in particular regulatory affairs (EU, international), biologicals development for animals, team management and trade associations. Deeply interested in animal health, environment, 3Rs and One Health topics, Corinne has held various membership and chair positions in European and International trade associations since 2006.  She is currently co-chairing the Health for Animals Regulatory Strategic Committee and she actively contributes to several European and International working groups on the 3Rs and on the environmental impact of medicines. 

Gabriel Bohl benefits from 25 years’ experience in International Regulatory Affairs across various therapy areas, with 20 years CMC experience and 10 years in large molecules – e.g. vaccines, ATMP/CGT and other biological products. Gabriel has been working in a large pharmaceutical company, in a health agency and in CROs. He has provided worldwide support on responses to CMC RA questions, is involved in RA meetings to discuss CMC issues, in CDMOs discussions, in Health Authorities meetings, and strategies, review and writing of various regulatory CMC documents. The CMC focus is on biological products (CGT/ATMP), fermentation products, GMOs (Genetically Modified Organism), proteins, various vaccines and biosimilars. Gabriel is supporting CMC risk assessments, CMC gap analysis, variations (life cycle management). Gabriel is leading a regulatory association for France, is part of other regulatory groups (CMC and Biotech), writing scientific articles, and is presenting / organizing conferences. He obtained Doctorate in Pharmacy (PharmD) and Master in Pharmacy from Louis Pasteur University in Strasbourg, France.

Katleen Abergel is a regulatory affairs project manager working at Genethon and she is based in Paris. She is a Doctor of Pharmacy and has a Master’s degree in Regulatory affairs for health industries (ARIS in Châtenay-Malabry) .  Additionally, she has 6 years of experience in pharmaceutical industry working in: Pre-registration activities (Scientific advice, pre-FIH activities with FDA and EMA), International department with several regions of the world (NME, Australia, US) in preparation/submission of the files to obtain MA and Q&A with health authorities, Regulatory pathways for ultra-rare disease (development plans and interactions with ANSM).
 

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
  • Once logged in click the 'Register Myself' button that will appear below.

Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.

Registration is free for TOPRA members and Non-members can register for £45 (which includes two months of TOPRA membership). Student membership of TOPRA is free and is available to full-time undergraduate students. 
 
When
23/05/2024 09:00 - 15:00
Where
ICON Plc 64 Avenue des Champs Pierreux Nanterre 92000 PARIS FRANCE
Sign in or create an account to register Registration ends 22/05/2024 12:00 (GMT Daylight Time)
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