Didier Caizergues | Director Of Regulatory Affairs
Genethon

Didier Caizergues, Director Of Regulatory Affairs, Genethon

A Doctor in Pharmacy, who holds a degree in Health law. He enjoyed a long career in the field of Regulatory Affairs.
He began his career as a consultant with International Drug Development (IDD), but soon joined the company SYNTHELABO in its Research and Development center where he worked for nine years. In this office Dr Didier CAIZERGUES oversaw the registration of new molecules that had evolved from cardiovascular, urological and anti‐depressive research.
He later headed up the international registration department for the Pierre Fabre group and for the next six years he practices to the fields of anti‐cancer drugs, anti‐depressants and orphan diseases.
In 2001 he joined the GENETHON as Director of International Regulatory Affairs where he set up a regulatory affairs department specialized in gene and cell therapies in the fields of rare diseases. He obtained several clinical trials authorization in European countries and US for gene therapy products with lentivirus and AAV in the fields of muscular dystrophies and paediatric immunodeficiencies. He also manages scientific advice with the European Medicines Agency. He is also in charge of the assessment of new molecules or molecules already marketed still in the field of rare diseases in different working groups in European projects (Treat‐NMD).

Appearances:



Conference Day 2 - Wednesday 1st April 2020 @ 15:40

Orphan Drugs Gene and Cell therapies product: The difficulties encountered and the supports proposed by the EC, EMA and National Agencies for the development and registration.

The development of these products is worldwide or at least European, we will highlight some of the problems met regarding missing of harmonization or the design of clinical trials. The regulators have developed some supports and expedited programs topromote the development of these orphan drugs. We will describe this during our presentation.
last published: 04/Jun/20 08:25 GMT

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