Event
Fit For ATMPs? Creating an EU Regulatory Framework that Works for Transformative Therapies
Hosted by the MEP Interest Group for Transformative Therapies (TRANSFORM)
RegisterThis meeting will bring together policy-makers (MEPs, representatives of EU institutions, national representatives), regulators (EMA), patient representatives, medical experts, scientists, researchers, industry representatives and academics to discuss recommended changes in policy and practice, and offer solutions to ensure a regulatory framework that is fit-for purpose for ATMPs and has patient safety at its centre.
The discussion will focus on legislative dossiers that touch on the ATMP regulatory framework, namely the review of the Blood, Tissues and Cells legislation (expected mid-July) and the General Pharmaceutical legislation.
A recording will be made available after the event.
Confirmed Speakers
Ondrej Knotek, MEP
TRANSFORM MEP Co-Chair (Renew, CZ)
Dr Alexander Natz
Secretary-General, EUCOPE
Dr Ana Hidalgo-Simon
Head of Advanced Therapies, European Medicines Agency
Stefaan Van der Spiegel
Head of Sector – Health Innovation, DG SANTE, European Commission
Radka Maxová, MEP
TRANSFORM MEP Member (S&D, CZ)
Dimitrios Athanasiou
Board Member of World Duchenne Organization and member of the EMA’s Paediatric Committee (PDCO)
Marcello Milano
Director R&D and Regulatory Policy EU, BioMarin
Prof Pauline Meij
Head of the Cell and Gene Therapy Facility, Leiden University Medical Center, member of the LERU Network
Dr Stefano Ferrari
Head of Research & Development at The Veneto Eye Bank Foundation, on behalf of the European Alliance for Vision Research & Ophthalmology (EU EYE)
Dr Martin Telko
Global Public Affairs Director for Biomedical Innovation, Novartis
Dr Vincenzo De Angelis
Director, Italian National Blood Centre; Coordinator of the GAPP-JA
Prof Giulio Cossu
Professor of Regenerative Medicine at the University of Manchester, on behalf of the Federation of European Academies of Medicine (FEAM)
Dr Androulla Eleftheriou
Executive Director, Thalassaemia International Federation (TIF)
Dr Paula Salmikangas
Director of Biopharmaceuticals and ATMP at NDA Group AB; Former Chair of EMA’s Committee for Advanced Therapies (CAT)
Simone Boselli
EU Public Affairs Director, EURORDIS – Rare Diseases Europe