Advanced Therapies and Personalised Medicines

Date: 24 April 2014 - 13:30
Location: De Montil, Affligem

13:30 Registration & Coffee

13:45 Welcome and speaker introduction
Ingrid Theeuwes, BRAS Education

13:55 Introduction on innovation
Prof. Dr. Walter Van Dyck, Associate Professor Innovation Management, Vlerick Business School

14:15 Legal frame

Legal frame ATMP
Dr Claire Beuneu , Non-clinical assessor and CAT Member , DG pre-Authorisation FAMHP
Legal frame personalized medicines
Greet Musch, Director General Pre-Authorisation – FAMHP

14:45 Regulatory strategy plan for successful submission of ATMP/personalized medicine – industry case
Marie-Claire Beurier, Global Regulatory Leader, Tarceva - Roche
The global regulatory experience of Tarceva for the 1st line NSCLC indication for patients with EGFR activating mutations.

15:05 Q&A

15:15 Coffee Break

15:40 Challenges in clinical trials
Ingrid Klingmann, MD, PhD, Chairman European Forum for Good Clinical Practice (EFGCP)

16:00 Panel discussion
Speakers and Representatives from Ethical Committees
Prof. Dr. Patrick Cras (UZ Antwerpen)
Prof. Luc Delattre (ULG )

16:30 End of the session

Fees: 150€ for BRAS Members - 350€ for non BRAS Members
Cancellation: In case of cancellation after 14 April 2014, the fees are due and will be invoiced.