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Cross-border Access to ATMPs in the European Union
Session Chair(s)
Paolo Morgese, MSC
Head of Public Affairs
Alliance for Regenerative Medicine (ARM), Belgium
The panel will discuss existing European regulations for cross-border access to ATMPs and challenges encountered by patients in getting treatment in centers outside their home country. In addition, the group will cover topics related to the complexity of ATMPs, to their manufacturing and administration; the resulting limitations in setting up treatment centers and the need for patients to seek treatment where is available. The panel will discuss case-studies and first-hand experience in overcoming these challenges.
Learning Objective : Improve understanding of EU cross border access regulations and real life experience
Speaker(s)
Panelist
Michela Gabaldo, PHARMD, MSC
Evotec, Italy
VP ATMP Global Regulatory Affairs
Panelist
Andrew Olaye, PHD, MPHARM, MSC
Orchard Therapeutics, United Kingdom
Senior Director, Head of EMEA Market Access
Panelist
Tresja Bolt
bluebirdbio, Belgium
Head of Public Affairs Europe
Panelist
Simone Boselli, MA
EURORDIS, Belgium
Public Affairs Director