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Speaker

Elissa Carney

Program Director

Online Information Session

Professional Program in Regulatory Affairs

Regulatory affairs professionals have a multidisciplinary role in the life cycle of the development process for a new drug or medical device. For example with drug development, to grow in the regulatory affairs role you need to develop knowledge at the bench, have an understanding of the Chemistry Manufacturing and Controls for both drug substance and drug product, as well as have a clinical/mechanistic understanding of what the drug product is designed to do.

In order to be a Regulatory Affairs professional, it is imperative that you have the understanding of the process to bring a drug product to market, which is achieved in part by learning, experiencing and being involved in each of the development process steps and interaction with the U.S. Food and Drug Administration or a respective health authority.

Our program teaches you FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP) principles and ethical considerations covering the development of drugs and dossiers for clinical trials and licensure, and provides the training to manage these activities. Learn more about this program and how you can get started.

What We'll Discuss

Various employment opportunities
Program curriculum requirements
Course options
Your practicing instructors
What our graduates go on to do
Your next step