FDAnews Announces -- Early Bird Pricing Ends on May 31, Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch Workshop June 28, 2019

Friday, May 24, 2019 General News
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Discover the new rules of play with top FDA counsel in this one-day crash course.

FALLS CHURCH, Va., May 24, 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

Early bird pricing for Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch ends on May 31.

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 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 and 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.

Early bird pricing ends on Friday, May 31.

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: Early Bird Pricing: $697 (available until May 31, 2019) Regular Pricing: $897 (after May 31, 2019) Livestreaming Early Bird Pricing: $597 (available until May 31, 2019) Livestreaming Regular Bird Pricing: $797 (after May 31, 2019) Significant team discounts are available.

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

About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

 

SOURCE FDANEWS



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