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7th Promotional Review Committee Compliance & Best Practice...
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Wednesday, May 13 • 9:00am - 12:00pm
Morning Workshop: Learn OPDP Expectations During a Sample Regulatory Review Scenario

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OPDP reviewers and outside counsel provide crucial feedback on your commercial pieces. By sitting in and learning from the thought processes of people familiar with OPDP’s review of your promotional materials, you can better understand how they take claims apart and how regulatory analysis may come down against you if you don’t have the right evidence. This interactive workshop enables you to internalize and work with OPDP expectations during a real-time “mock” review meeting. The interactive workshop will also enable you to recognize where real world evidence (RWE) may play a role as a source of evidence for both regulatory and medical products coverage or reimbursement decisions.
  • Clarify where your expectations of labeling and promotional information differ from those of OPDP reviewers
  • Zero in on areas where terminology use may cause confusion from a regulatory perspective
  • Explain what “adequate substantiation” means and how to apply the “competent and reliable scientific evidence” standard in a manner that is consistent with FDA’s approach for the substantiation of promotional claims
  • Gain understanding of truthful, balanced, and accurately communicated information
  • Anticipate the level of investment in both time and resources required for successful review

Speakers
avatar for Cristina Masseria

Cristina Masseria

Methods and Capabilities Lead, Pfizer
Cristina is currently leading the Methods and Capability team for HEOR and Market Access at Pfizer. Cristina has extensive experience in HEOR and RWD generation and communication in Pharma (Pfizer and GSK).Before joining the pharmaceutical industry in 2011 at GSK, Cristina was a lecturer... Read More →
avatar for Keren Tenenbaum

Keren Tenenbaum

VP and Assistant General Counsel, Head of Legal, Salix at Bausch Health
avatar for Nneka Onwudiwe, PharmD., Ph.D., MBA

Nneka Onwudiwe, PharmD., Ph.D., MBA

Founder and Chief Executive Officer, Pharmaceutical Economics Consultants of America (PECA) LLC
Nneka C. Onwudiwe, Ph.D., Pharm.D., MBA, received her doctorate in Pharmacy (Pharm.D.) from the University of Maryland School of Pharmacy, Ph.D. in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors... Read More →


Wednesday May 13, 2020 9:00am - 12:00pm