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FDA regulations and the latest guidance’s finalized a flexible policy for how drug and device manufacturers can discuss payments, outcomes, and healthcare data.
Promotional review professionals face new challenges from the rapid growth of social media, to the popularization of online regulatory submission, to the still-developing shockwaves released by 1st Amendment court decisions about off-label communication. And even as those new challenges arise, PRCs must always be able to gather and organize input from multiple disciplines, make their deadlines, and ensure the review process moves smoothly and without mistakes.
Top Five Reasons to Attend:
-Latest analysis about off-label messaging and scientific exchange after recent 1st Amendment court decisions
-Detailed strategies for improving your promotional review approach for social networks and adaptive websites
-Best practice for communications with payers and managed markets
-Troubleshooting ad/promo submissions through the eCTD gateway
-In-depth, interactive workshop about ensuring promotional compliance
Time: 9:00 am - 5:00 pm
Speakers: Rebecca Burnett Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS INC., Jill Charbonneau Director, Regulatory Affairs, HARMONY BIOSCIENCES, INC., Ian DeMerrit Medical Director, FINGERPAINT, Howard Dorfman Founder, H.L. DORFMAN CONSULTING, Janet Gottleib Associate Director, ALLERGAN, Kate Ho Manager and Regulatory Affairs Advertising Promotions, TESARO BIOSCIENCES, Anita Kachappilly Manager, Regulatory Affairs – Advertising, Labeling, and Promotion, BIOGEN, Nicole Lare Associate Director, Regulatory Affairs Advertising and Promotion, MALLINCKRODT, Richard Lem Associate Director, Regulatory Affairs, Advertising and Promotion, BAYER, Doreen V. Morgan Vice President, U.S. Regulatory Affairs, VP OF U.S REGULATORY AFFAIRS AND QUALITY ASSURANCE, Tiffany Mura Director, Consumer and Digital Marketing, ALKERMES, Linda Pissott Reig Co-Chair, BIONJ LEGAL, COMPLIANCE, and REGULATORY GROUP Adjunct Professor, Management and Global Business, RUTGERS BUSINESS SCHOOL, Linda Pollitz Senior Director, Regulatory Affairs, Advertising and Promotion, ALKERMES, Denise Sanchez Executive Director, Regulatory Affairs Advertising and Promotion, ALLERGAN, Denice Simon Assistant General Counsel, TAKEDA, Kathy Tavakoli Regulatory Affairs Advertising and Promotion, LUPIN PHARMACEUTICALS, Gina Vestea Senior Director, Regulatory Affairs, GENZYME, Gary Wieczorek Director, Regulatory Affairs, ABBVIE
Early Bird Pricing- Conference Only: USD 1795.0,
Early Bird Pricing- Conference + 1 Workshops: USD 2095.0,
Early Bird Pricing- Conference + 2 Workshops: USD 2295.0,
Standard Pricing- Conference Only: USD 1995.0,
Standard Pricing- Conference + 1 Workshop: USD 2295.0,
Standard Pricing- Conference + 2 Workshop: USD 2495.0,
Onsite Pricing- Conference Only: USD 2095.0,
Onsite Pricing- Conference + 1 Workshop: USD 2395.0,
Onsite Pricing- Conference + 2 Workshop: USD 2595.0
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Ratings & Reviews for 7th Promotional Review Committee Compliance and Best Practices
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