RAPS DC/Baltimore Chapter In-Person Event: FDA Panel Event and Summer Mixer at Arnold & Porter

The RAPS DC/Baltimore Chapter and Arnold & Porter invite you to join us for an educational and networking event at Arnold & Porter's headquarters in Washington, D.C. on July 9. This event will include panel discussions by industry experts, current and former FDA leaders, and regulatory counsel to bring you the latest thought leadership on topics of current interest to regulatory affairs professionals.

Topics are intended to appeal to a broad regulatory audience across therapeutic modalities including pharmaceuticals, biologics, medical devices, and combination products. Topics are intended to appeal to a broad regulatory audience across therapeutic modalities including pharmaceuticals, biologics, medical devices, and combination products. Our opening panel will cover advances in the availability and use of real-world data and real-world evidence for regulatory decision-making, updated FDA guidance, and FDA's latest thinking on real-world evidence in market submissions.

Following the opening panel, two breakout sessions will give attendees the choice to dive deep into preparing for FDA inspections and oversight or managing development and commercialization of combination products. Both sessions will offer in-depth discussion of current issues, FDA expectations, industry experience, and regulatory requirements. The evening will finish with a networking event for attendees to enjoy the monument view from Arnold & Porter's Garden Room and roof deck, connect with local regulatory professionals, and continue conversations sparked by the panel content.

Opportunities to learn more about RAPS membership, certifications, and other resources will also be available on site.

Agenda

• 2:30 p.m. - Registration
• 3 p.m. - Welcome, Introductions, and Review of Agenda
• 3:10 p.m. - Using Real-World Evidence in Medical Product Applications
• 4 p.m. - Break
• 4:10 p.m. - Session A: Preparing for FDA Inspections and Oversight
• 4:10 p.m. - Session B: Managing Development and Commercialization of Combination Products
• 5 p.m. - Closing
• 5:15 p.m. - Networking Reception

Speakers

• Alonza Cruse | Director of the Office of Pharmaceutical Quality Operations at FDA
• Philip Desjardins* | Partner at Arnold & Porter
• Joe Franklin* | Chief Counsel of Regulatory & Strategic Affairs at Verily
• Abeba Habtemariam | Partner at Arnold & Porter
• Stephanie Haggerty | Senior Corporate Counsel at Pfizer
• Carrie Kuehn | Founder at Evergreen Strategic Consulting
• Sarah Mollo | Combination Product Policy Analyst at FDA-CDRH
• Bahram Parvinian* | Founder at Lighthouse Regulatory Consulting
• Howard Sklamberg* | Partner at Arnold & Porter
• Rumi Young* | Director of Regulatory Policy at Novo Nordisk

*Former FDA