LAUNCH & PATIENT ACCESS CONCURRENT Regulatory revolution: global harmonization for safe personalized medicines
Friday, June 2, 2023 05:00 PM - 06:00 PM
Amphitheatre Bleu
LAUNCH & PATIENT ACCESS
Concurrent
Chairs
Phil Vanek, PhD, CTO & Partner, Gamma Biosciences, USA
Speakers
Aurélie Mahalatchimy, PhD, CNRS Permanent Researcher, Aix-Marseille Université & EuroGCT, France
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, United Kingdom
Paula Salmikangas, PhD, Director of Biopharmaceuticals and ATMP, NDA Group, Finland
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration, USA
In this session, a panel of regulatory experts will discuss what the future needs to look like to support commercialization of therapies globally. Importantly, panelists will discuss whether this future necessarily entails the harmonization of global regulatory pathways.
Phil Vanek, PhD, CTO & Partner, Gamma Biosciences, USA
Speakers
Aurélie Mahalatchimy, PhD, CNRS Permanent Researcher, Aix-Marseille Université & EuroGCT, France
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, United Kingdom
Paula Salmikangas, PhD, Director of Biopharmaceuticals and ATMP, NDA Group, Finland
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration, USA
In this session, a panel of regulatory experts will discuss what the future needs to look like to support commercialization of therapies globally. Importantly, panelists will discuss whether this future necessarily entails the harmonization of global regulatory pathways.