Hi RegEx members,
I hope you have had some time to check out the recently released Regulatory Focus Article Series: The Shifting Global Regulatory Landscape. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 8 July, from 1:30-2:30 PM ET here 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.
Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, is executive director of the Device and Digital Health Group, focusing on medical devices and combination products, at Merck (Upper Gwynedd, PA). Before joining Merck, he accumulated 16 years of experience in many facets of the product development lifecycle, including regulatory submissions and due diligence. He has actively participated with industry trade organizations and on standards committees. His time as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Oppenheimer has two master’s degrees, in biotechnology and in regulatory science, and has a graduate certificate in biotechnology enterprise, all from Johns Hopkins University. He completed his DRSc in regulatory science at the University of Southern California in 2016. He is a RAPS Fellow and serves on the editorial advisory committee for RAPS Regulatory Focus and the editorial board of the Institute of Validation Technology.
If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me an email at regex@raps.org.
Looking forward to hearing your thoughts and reading your questions!
Best Wishes,
Annie
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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org------------------------------