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ATMP REGULATIONS - ONGOING REVIEW
Session Chair(s)
Paula Salmikangas, PHD
Advisory Board, Director of Biopharmaceuticals and ATMPs
NDA Group, United Kingdom
With Regulation 1394/2007/EC the legal framework is now built for ATMPs in EU. It has provided certainty and predictability for the development of ATMPs and set the requirements for their authorisation. However, many aspects of the legislation have been found problematic, as can be seen from the results of the European Commission consultation concerning the ATMP regulation and the subsequent EC report, published in April 1st, 2014. The comments received and conclusions of the EC report call for revision of the legislation, but what should be changed and how?
Speaker(s)
Need for Revision of the ATMP legislation?
Rocio Salvador Roldan
European Commission, Belgium
Policy Officer
Bottlenecks for ATMP Development
Alex Bloom, PHD
Chiesi Farmaceutici, United Kingdom
Manager, Global Regulatory Affairs, Biotechnology & Advanced Therapies
Boundaries between ATMPs and Transplant/Transfusion Products, Revision of Guidance on ATMP Classification
Marit Hystad
Norwegian Medicines Agency, Norway
Head of Unit