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Documents New regulatory requirements for first into man studies in France Dominique Tremblay External Expert....

Slide 1New regulatory requirements for first into man studies in France Dominique Tremblay External Expert at the French Medical Agency Agence Française de Sécutrité Sanitaire…

Technology M C04 2009

1.Medicinal Chemistry & Molecular Design Programa de doctorado: “ Mechmod” Universitat de Girona Dr. Antonio Delgado Profesor Titular de la Universidad de Barcelona…

Technology Mc06 2009

1.Dr. Antonio Delgado Profesor Titular de la Universidad de Barcelona Facultad de Farmacia Unidad de Química Farmacéutica (Unidad Asociada al CSIC) (Abril-Mayo 2009) MC06:…

Documents The FDA Review Process

The FDA Review Process Dan Takefman, PhD Chief, Gene Therapy Branch DCGT/OCTGT/CBER/FDA IOM Meeting 6/4/13 Overview IND Review Process Regulatory framework Discipline review…