FDAnews Announces -- Post-Market Surveillance: The New World of Compliance, Liability and Best Practices Program on May 16, 2019 in Washington, DC

Tuesday, March 12, 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., March 12, 2019 /PRNewswire-PRWeb/ -- 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 one discovers how to survive this brave new regulatory world.

Mark the calendar for the 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 ones 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 Alston & Bird under the guidance of partner Cathy Burgess Esq., moderator. Her presentation team comprises partner Marc Scheineson Esq., senior associate Brendan Carroll Esq., and associates Seth Olson Esq. and Justin Mann Esq.

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 8:30. 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 Alston & Bird'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 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 it's done right.

Who Will Benefit: This workshop is a must for drug, biologics, device and diagnostics makers. If ones title is among the following, make plans now to attend:

  • Quality management
  • Regulatory affairs
  • Compliance
  • Strategic planning
  • Legal counsel
  • C-Suite executives

Meet the Chairperson: Cathy L. Burgess Esq., Partner, Alston & Bird.

Ms. Burgess focuses on FDA-related regulatory compliance, risk management, enforcement and policy matters affecting clients involved in Rx and OTC drugs, biologics, medical devices, food and cosmetics. She has an interest in cGMP regulation, advising clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls and responses to Forms 483 and warning letters. She conducts internal investigations and special audits and helps clients design compliance and internal audit programs plus other risk mitigation strategies. She has been recognized as an outstanding practitioner in her specialties by Who's Who Legal, The Best Lawyers in America© and Chambers USA.

Webinar Details: Post-Market Surveillance: The New World of Compliance, Liability and Best Practices Law Offices of Alston & Bird LLP • Washington, DC **An Interactive All-Day Workshop** Thursday, May 16, 2019 https://www.fdanews.com/postmarketsurveillance

Tuition: Early Bird Pricing: $1,597 (available until April 9, 2019) Regular Pricing: $1,797 (after April 9, 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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