The RAPS DC/Baltimore Chapter and Arnold and Porter invite you to join us for an educational and networking event at the Arnold and Porter headquarters in Washington, D.C.on July 9th. This event will include panel discussions by industry experts, 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. Our opening panel will address the use of Real-World Evidence in Medical Product Applications. Panelists 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 RWE 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 roof-top views of the Arnold and Porter building, 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.
Registration Fees & Deadlines
Free
Agenda
- 2:30 pm Registration
- 3:00 pm Welcome, Introductions, and Review of Agenda
- 3:10 pm Using Real-World Evidence in medical Product Applications
- 4:00 pm Break 4:10 pm - A Preparing for FDA Inspections and Oversight
- 4:10 pm – B Managing Development and Commercialization of Combination Products
- 5:00 pm Closing
- 5:15 pm Networking Reception
Speakers
Chuck Medovich
Vice President and Chief Quality Officer, Johnson and Johnson
Carrie Kuehn
Principal Consultant & Founder, Evergreen Strategic Consulting
Bahram Parvinian
Principal Consultant, Lighthouse Regulatory Consulting
Sponsor
Arnold & Porter
Will be providing the covering the registration, space, food, and refreshments for this event
Location
Arnold & Porter
601 Massachusetts Ave NW
Washington, DC 20001
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org