Regulatory Affairs Expert Program

Learn the essential elements of regulatory affairs related to the pharmaceutical & medical device industries.This program that will provide you with the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition.
This certificate program will provide you with the fundamental skills you need to be an expert in regulatory affairs..

Objetivos

farma

Disponible en formato e-learning

Disponible en formato presencial

Disponible en formato a distancia

Subvención disponible
A través de Fundae, cumpliendo requisitos.

Duración
12 horas

  • Dificultad 50% 50%
  • Nivel alcanzado 80% 80%

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Conocimientos requeridos

Temario

Regulatory affairs focused on clinical development
The role of regulatory affairs in advertising & promotion
Understand the difference between clearance vs. approval
Different types of regulatory submissions and applications
U.S. Drug & Biologics Labeling, Advertising & Promotion
Understand the regulatory system in Europe & Canada
Includes Common FDA forms used by regulatory affairs

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