Regulatory Affairs for Medical Device Clinical Trials

Clinical trials are conducted in compliance with regulations. 

Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices.

As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework.

To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show.

In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States.

She does a great job of tailoring our conversation to make it applicable for clinical trial professionals.

We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more.

The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic.

Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast.


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