FDA’s Sentinel System… the iMEDS Program… Rapid technological change…
Post-market surveillance can be mind-boggling. The FDA is requiring drug and device manufacturers to make more accurate assessments of how a product is marketed, sold and used in practice to determine more precisely the degree of safety and efficacy and any resulting adverse events.
Here’s how to master the new rules — quickly, confidently, authoritatively.
Mark your calendar for Friday, June 28, when FDAnews and Covington & Burling will conduct a full day of interactive learning featuring top FDA lawyers from Covington & Burling, plus a key FDA regulator. Be ready to discover:
- Successful strategies for drug pharmacovigilance
- Device post-market surveillance tools, including the role of 522 Postmarket Studies
- Public-private partnerships: How the Sentinel and iMEDS programs can help in your PMS
- 21st Century Cures Act & PDUFA VI: New FDA initiatives and opportunities
- Real world evidence: How to use it effectively for post-market surveillance.
- Horror stories and hypotheticals: Post-market surveillance nightmares to avoid
- And much more!
Your faculty includes an all-star legal cast from the FDA regulatory team at Covington & Burling including Kristin Davenport, Paula Katz, Christina Kuhn, Gary Heimberg, Krista Carver and Matthew Hegreness.
A highlight of the day is the luncheon presentation featuring an FDA regulator. Invitations are pending to top agency officials with post-market regulatory authority.
The workshop takes place in Covington & Burling’s Washington offices, located in the heart of the nation’s capital. You’re surrounded by fine dining, shopping and world-class museums.
Accommodations are on your own, so here’s a suggestion: Tack on a day or a long weekend and enjoy the nation’s capital in glorious spring, our finest season.
Ensuring your products are safe and effective once they reach the market is all-important — to safeguard patient well-being, avoid lawsuits and liability, stay clear of warning letters and Forms 483. Make sure you do it right.