Meet Representatives of the Belgian Agency, FAMHP

Meet Representatives of the Belgian Agency, FAMHP
Members of the TOPRA IN Benelux Community Steering Group are pleased to invite you to a webinar during which representatives of the Belgian Federal Agency of Medicines and Healthcare Products (FAMHP) will present the current organisation and the key activities on which the Agency is focussing in line with its strategic business plan. The webinar will cover the key three divisions of the Agency: Directorate General (DG) Pre-Authorisation, DG Post-Authorisation and DG Inspection.



Date: Tuesday 13 May 2025
Time: 12:00 - 13:00 BST 13:00 - 14:00 CET


Benefits for participants

This is a unique opportunity to meet representatives from the Agency and hear updates on how it is organised, what its historical and new spearhead areas are and what its core activities and contributions in a European context are. And this with an opportunity to ask questions.

In this webinar, we will specifically cover:

          - The three divisions (Directorate General) of the FAMHP Organisation
          - It’s core activities in the areas of human and veterinary medicinal products as well as in medical devices.
          - The spearhead areas and strategic business priorities of the Agency



Presenter(s)

Ann Verhoye, Staff Co-worker, FAMHP
Ann is an industrial pharmacist, active in regulatory affairs for almost 25 years. She joined the Belgian national competent authorities in 2000 as a quality assessor. 

Since 2009, she is supporting the Director-General DG PRE-Authorisation focussing on technical/regulatory-scientific advice, clinical trials, marketing authorisation, and compassionate use/medical need programs.

Christophe Debruyne, Management Support Co-ordinator DG Inspection, FAMHP.
Christophe obtained his degree in veterinary medicine from the University of Ghent in 2003. He started working for FAMHP in 2004 (known at the time as DG Medicinal Products). Until 2010, he was responsible for the coordination of all veterinary Mutual Recognitions Procedures (MRPs) and Decentralised Procedures (DCPs) and he was a member of the Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv), Notice to Applicants (NtA) and Quality Review of Documents (QRD). In 2010, he became an inspector, specialising in publicity, veterinary pharmacovigilance and veterinary Good Clinical Practice (GCP) and since 2020, he has coordinated the management support team of DG Inspection.

Sara De Clercq, Management Support DG Post Authorisation, FAMHP.
Sarah is a biological engineer with a PhD in biomedical science. She joined the Belgian agency in 2016. Since then, she has worked on publicity dossiers and coordinated a variety of projects including the implementation of the national action plan on antimicrobial resistance in humans as far as the agency's competences are concerned and the development of a new platform for clear and understandable information for patients on medicines and health products. 

Since 2024, she has also supported  the Director-General DG POST and continues to coordinate the elaboration of the national action plan on antimicrobial resistance in humans.
 
The session will be facilitated by Frank Vandendriessche and Paula van Hennik as co-chairs of the TOPRA IN BeNeLux Community Steering Group


Frank Vandendriessche is a Pharmacist with PhD and has been active in scientific and strategic regulatory affairs from more than 25 years at three major companies (Pfizer AH, GSKBiologicals, MSD) and as a regulatory affairs consultant for 10 years.



Paula van Hennik has a background as a scientist with a PhD in Haematology and has been active in the field of (clinical) regulatory affairs for 14 years with experience as a regulator (11 years at the Medicines Evaluation Board) and since 2 years as a consultant. 


The main webinar presentation will run for approximately [50] minutes, which will then be followed by a Q&A session.


PRICING
TOPRA Members: Free 
Non-member: £45
When
13/05/2025 12:00 - 13:00
Where
ONLINE
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