RegEx Community Ask Me Anything Session: The Shifting Global Regulatory Landscape

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Wednesday, 08 July 2020 (1:30 PM) - Wednesday, 08 July 2020 (2:30 PM) Eastern Time (US & Canada)

To support the launch of the Regulatory Focus Article Series: The Shifting Global Regulatory Landscape we will be hosting an "Ask Me Anything" session on Wednesday, 8 July, from 1:30-2:30 PM ET on RegEx. Three regulatory experts, Siegfried Schmitt, Jordanna Jayne, and Tammy M. Pelnik. will be available to discuss the articles and answer your questions in real time.

About the experts:

Siegfried Schmitt, PhD, is a vice president‒technical with Parexel, providing services to the regulated healthcare industry. He is a recognized subject matter expert in data integrity. Schmitt currently serves as the pharmaceuticals and biologics sector lead on the RAPS Regulatory Focus editorial advisory committee.

Jordanna Jayne, PhD, is a regulatory affairs specialist at the Hologic, Inc. diagnostic division based out of San Diego, California. She recently received her PhD in clinical and experimental theraptics and her master's degree in regulatory science from the University of Southern California (USC) School of Pharmacy.  

Tammy M. Pelnik, MS, has spent more than 27 years working in quality management and quality assurance for medical device and drug-device manufacturers. She is president of St Vrain Group, Inc., a Colorado-based consulting firm, providing cost-effective QMS implementation, creative QMS strategic planning, QMS auditing and innovative compliance training. Pelnik is an IRCA principal QMS auditor and an ASQ certified manager of quality/organizational excellence and quality engineer.

If you cannot make the session, please feel free to submit any questions ahead of time by sending an email to regex@raps.org.

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