New regulatory requirements for first into man studies in France Dominique Tremblay External Expert at the French Medical Agency Agence Française de Sécutrité.
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical Trials
Background and Objectives of Ongoing Studies
Please Note: Due to technical difficulties the medical contrast images will not be in motion, the images will appear as still pictures. For medical images.
First In Human Pediatric Trials and Safety Assessment for Rare and Orphan Diseases Andrew E. Mulberg, MD, FAAP Division Deputy Director OND/ODE3/DGIEP.
