New regulatory requirements for first into man studies in France Dominique Tremblay External Expert at the French Medical Agency Agence Française de Sécutrité.
Minimizing risk by optimizing clinical trial design AGAH Workshop 19 April 2008
John Posner Human Pharmacology Training Programmes – UK.
Relevance of pre-clinical findings for the interpretation of Adverse Events
1 Minimizing risk by optimizing clinical trial design AGAH Workshop 19 April 2008 Workshop Minimizing risk by optimizing clinical trial design and performance.
Clinical Trial Authorisation in Germany for First-in-Man Trials with NCEs