7th Promotional Review Committee Compliance & Best Practice - Midwest

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