WCG FDAnews Announces: Engaging with the FDA Webinar on December 1, 2022

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WCG FDAnews

Nov 21, 2022, 13:00 ET

Knowing how to effectively engage with the FDA, allows pharmaceutical and medical device manufacturers to navigate serious agency actions such as responding to warning letters, product seizures and injunction proceedings, and achieve positive results. Communication is critical to manufacturers' ability to mitigate fallout and achieve positive results from agency actions.

FALLS CHURCH, Va., Nov. 21, 2022 /PRNewswire-PRWeb/ -- Steve Silverman, president of The Silverman Group, and former director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance and assistant director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance, will share how to engage effectively with the FDA.

He will explain what effective FDA engagement is, what it will and will not provide, the best engagement practices, and the right level of engagement.
Webinar Takeaways:

  • What effective FDA regulatory engagement means as well as misperceptions to be aware of
  • The four essential principles of effective regulatory engagement: informed, trust-based, timely, appropriate
  • The three steps to achieve effective regulatory engagement
  • How novel issues like digital technology and real-world evidence influence effective regulatory engagement
  • What to do when things go wrong, e.g., when communication fails or when the FDA decides to take enforcement action

Webinar Details
Engaging with the FDA
Best Practices for Dealing with Warning Letters, Seizures, Injunctions — and More
An FDAnews Webinar
Thursday, December 1, 2022, 11:00 a.m.–12:30 p.m. EST
https://wcg.swoogo.com/engaging-with-the-fda

Price:
$287

Easy Ways to Order:
Online: https://wcg.swoogo.com/engaging-with-the-fda
By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:
WCG 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 WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.

Media Contact

Michelle Butler, WCG FDAnews, 703.538.7665, [email protected]

SOURCE WCG FDAnews