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ATMPS -CLINICAL TRIAL DESIGN CHALLENGES FOR ATMPS AND MEDICINAL PRODUCTS FOR RARE DISEASES
Session Chair(s)
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics
Voisin Consulting Life Sciences, United Kingdom
We aim to cover the potential pitfalls that could affect the development & approval of advanced therapies which are by nature complex. The principles behind translating the products from bench-to-bedside that are critical for successful development.
Learning Objective : The attendees will learn how to plan the non-clinical and clinical development of complex biologicals such as advanced therapies.
Speaker(s)
Regulatory Requirements for ATMP Clinical Trials
Gopalan Narayanan, MD, FFPM, FRCP
Voisin Consulting Life Sciences, United Kingdom
Vice President, Disruptive Biologics
Clinical Study Designs and Possible Challenges for ATMPs
Etienne Sokal
Promethera Biosciences, Belgium
CEO
Statistical Considerations?
Tomasz Burzykowski
IDDI, Belgium
Vice-President
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