1 Week Until Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch Workshop June 28, 2019 Washington, DC

Discover the new rules of play with top FDA counsel in this one-day crash course.

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Jun 21, 2019, 00:00 ET

FALLS CHURCH, Va., June 21, 2019 /PRNewswire-PRWeb/ -- Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch
What You Need To Do To Comply with Agency Rules, Avoid Liability, and Implement Best Practices
**Law Offices of Covington & Burling • Washington, DC**
An Interactive All-Day Workshop • Thursday, June 28, 2019
https://www.fdanews.com/postmarketsurveillance

Post-Market Surveillance How FDA Regulates Your Medical Product after Launch
Workshop starts in one week.

Driven by changes in technology, public pressure and regulatory philosophy, FDA regulation is undergoing once-in-a-generation change. And nowhere has change struck faster or harder than in post-market regulation.

Drugs, biologics, devices, diagnostics … everyone is affected. It's high time to discover how to survive this brave new regulatory world.

Mark the calendar for a first-ever all-day session focusing on the challenges of post-market compliance. It's a rare opportunity to knock heads ¬— and break bread — with top FDA regulators and the Washington lawyers who cross swords with them every working day.

In a full day of interactive presentations, attendees will discover:

  • Successful strategies for drug pharmacovigilance under CDER
  • Understanding device post-market surveillance under CDRH & §522
  • Public-private partnerships: How the Sentinel and iMEDS programs can help in PMS
  • 21st Century Cures & PDUFA VI: New FDA initiatives and opportunities
  • Real world evidence: How to leverage it to the best advantage
  • Horror stories and hypotheticals: Post-market surveillance nightmares to avoid
  • And much more!

Faculty includes an all-star legal cast from the FDA regulatory team at Covington & Burling under the guidance of Scott Danzis. His presentation team comprises of 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.

Registration starts promptly at 8:00. Panels and luncheon run through the cocktail hour, followed by … cocktails of course and … networking. It's one of many chances throughout an information-filled day to share concerns with presenters and compare notes with fellow attendees. Registration includes two refreshment breaks … plus networking reception … plus handouts and materials attendees will rely on months after this workshop becomes a memory.

The workshop takes place in Covington & Burling's Washington offices, located in the heart of the nation's capital. One will be surrounded by fine dining, shopping and world-class museums. Accommodations are not designated, 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 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 to do it right.

Reminder: Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch Workshop starts in one week.

Webinar Details:
Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch
What You Need To Do To Comply with Agency Rules, Avoid Liability, and Implement Best Practices
**Law Offices of Covington & Burling • Washington, DC**
An Interactive All-Day Workshop • Thursday, June 28, 2019
https://www.fdanews.com/postmarketsurveillance

Tuition:
Regular Pricing: $897
Livestreaming Regular Pricing: $797
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/postmarketsurveillance
By phone: 888-838-5578 or 703-538-7600

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