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Virtual

Mar 15, 2021 9:00 AM - Mar 19, 2021 4:30 PM

(Central Europe Standard Time)

DIA EUROPE 2021

Cross-border Access to ATMPs in the European Union

Session Chair(s)

Paolo  Morgese, MSc

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)

Michela  Gabaldo, PharmD, MSc

Panelist

Michela Gabaldo, PharmD, MSc

Evotec, Italy

VP ATMP Global Regulatory Affairs

Andrew  Olaye, PhD, MPharm, MSc

Panelist

Andrew Olaye, PhD, MPharm, MSc

Orchard Therapeutics, United Kingdom

Senior Director, Head of EMEA Market Access

Tresja  Bolt

Panelist

Tresja Bolt

bluebirdbio, Belgium

Head of Public Affairs Europe

Simone  Boselli, MA

Panelist

Simone Boselli, MA

EURORDIS, Belgium

Public Affairs Director

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