Hi RegEx Members,
The fourth quarterly Regulatory Focus (RF) Article Series is here! In this RF series you will find a collection of insightful articles covering global Advertising, Promotion and Labeling (APL) regulations. We have had the pleasure of bringing together some of the top regulatory thought leaders from around the world-all with diverse backgrounds-to offer their expertise to help clarify and perhaps solve today's most pressing APL challenges.
Individual articles in this series examine:
- The Changing Regulatory Landscape of Advertising and Promotion
- Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise
- Pregnancy and Lactation Labeling Rule: Strategies for Updating Prescription Drug Labels for Compliance
- FDA's Off-Label Promotion Efforts
- Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product
- Medical Device Marketing Under Substantial Equivalence-FDA Clearance and USPTO Patent Considerations
- Regulatory Challenges in Mobile Medical Applications
- Australian Regulatory Framework of Over-the-Counter and Complementary Medicine
- Canadian Drug Advertising Regulations
Download the latest RF Article Series here.
Mark your calendars: To support the launch of the Article Series, we will be hosting an "Ask me Anything" session on Wednesday, 12 December, from 1:30 PM-2:30PM EDT here on RegEx. Five APL experts, Linda Pollitz, Julie Batel, Richard Lem, Georgina Lee, and John Wong will be available to discuss the articles and answer your questions in real time.
About the experts:
Linda Pollitz, RAC, senior director regulatory affairs, advertising and promotion for Alkermes, a global biopharmaceutical company, has more than 20 years of regulatory affairs experience involving medical devices, drugs, biologics, cell and gene therapies. She has been focusing on advertising and promotional labeling since 2001. Pollitz is a frequent speaker at conferences on drug advertising, promotion and compliance, and serves as an adjunct profession and invited guest lecturer at Regis College (Weston, MA) in their Master's Program in Pharmaceutical Product Development and Regulation. Pollitz is RAC certified, and has authored articles and book chapters for RAPS. She has been a member of the RAPS Board of Editors since 2014.
Julie Batal, MBA, JD is a vice president and head of regulatory labeling at Shire and is responsible for oversight and management of product labeling for Shire's commercial products.
Georgina Lee, PharmD, is an associate director, Regulatory Affairs Advertising, Promotion and Labeling at Agios Pharmaceuticals, Inc.
Richard Lem, PharmD, is an associate director in the Regulatory Affairs Advertising and Promotion Group at Bayer Pharmaceuticals, Inc.
John K. Wong, MSc Pharm, is a pharmacist graduated from Université Laval. He started his career at the Toronto General Hospital as a clinical pharmacist in oncology. He later joined the Pharmaceutical Advertising Advisory Board (PAAB), the national regulatory body for prescription drug advertising and became the deputy commissioner/chief review officer in 2001. After 10 years at PAAB, Wong joined Ogilvy CommonHealth as an account director where he helped launch specialty products into the Canadian market in oncology, urology, hematology, HIV and immunology (vaccines). He is now the director, regulatory drug advertising and promotion at TPIreg/Innomar Strategies.
If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me a private message.
Looking forward to hearing your thoughts on this article series.
Best,
Emily
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org------------------------------