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Le Palais des Congrès

Apr 13, 2015 9:00 AM - Apr 15, 2015 5:30 PM

2, Place de la porte Maillot, F-75017 Paris, France

27th Annual EuroMeeting

ATMPS -CLINICAL TRIAL DESIGN CHALLENGES FOR ATMPS AND MEDICINAL PRODUCTS FOR RARE DISEASES

Session Chair(s)

Gopalan  Narayanan, MD, FFPM, FRCP

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)

Gopalan  Narayanan, MD, FFPM, FRCP

Regulatory Requirements for ATMP Clinical Trials

Gopalan Narayanan, MD, FFPM, FRCP

Voisin Consulting Life Sciences, United Kingdom

Vice President, Disruptive Biologics

Etienne  Sokal

Clinical Study Designs and Possible Challenges for ATMPs

Etienne Sokal

Promethera Biosciences, Belgium

CEO

Tomasz  Burzykowski

Statistical Considerations?

Tomasz Burzykowski

IDDI, Belgium

Vice-President

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