Hi RegEx members,
I hope you have had some time to check out the recently released Regulatory Focus Article Series: Regulatory Strategy for Drugs and Devices. To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 30 September, from 1:30-2:30 PM EDT here on RegEx. Two regulatory experts, Manfred Ruthsatz and Jen Multari, will be available to discuss the articles and answer your questions in real time.
About the experts:
Manfred Ruthsatz, PhD, RAC, FRAPS, is the executive director of Nutrition+HealthCARE, Connecting Advocacy, Regulatory, and Empathy. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics, and reimbursement, spans more than 30 years in diverse healthcare industry settings, FDA CDER's Division of Antiviral Drug Products, and NIH's National Cancer Institute, working on human papilloma viruses. His publishing and speaking activities in Europe, the US, Asia, and Latin America include an array of regulatory- and policy-related healthcare topics, with a focus on nutrition in health and disease prevention and treatment, the human microbiome, and healthy longevity. He is a member of the IS_MIRRI21 advisory board and the RAPS editorial advisory committee.
Jen Multari, MSc, RAC, is currently head of global publishing operations at Boehringer Ingelheim (Germany). She is responsible for the end-to-end processes around submission publishing, publishing processes and vendor management. Her experience includes director of regulatory operations at Mallinckrodt Pharmaceuticals and medical writing at Pfizer. Multari thrives on the topics of submission management and systems, process improvement and team transformation. She earned a Master of Science in European regulatory affairs from Danube University Krems.
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------------------------------