Engaging with the FDA: Best Practices for Dealing with Warning Letters, Seizures, Injunctions — and More – Webinar Recording/Transcript
Communication is key to navigating serious FDA actions, such as warning letters, product seizures and injunction proceedings. When you know how to keep the lines of communication open, you can mitigate the fallout and achieve positive results.
Interacting effectively with the FDA through meetings, personal communication, inspections, application reviews and more can help ease your way through the regulatory thicket.
Learn how to put your best foot forward when engaging the FDA by attending this presentation given by a former FDA official.
Steve Silverman, president of The Silverman Group, was previously 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.
And now he’s going to share with you how to engage effectively with the FDA.
He’ll explain what effective FDA engagement is, what it will and will not provide, best engagement practices and the right level of engagement.
Mr. Silverman will reveal how product and regulatory innovation affects engagement scope and practices. And together you’ll explore serious FDA actions: what they are, their business impact and how effective engagement underpins positive results.
He’ll even divulge how to get back on track when engagement goes wrong: when it veers off course and when it occurs during the most challenging circumstances, such as regulatory correspondence (FDA untitled and warning letters), product import alerts and agency legal action.
- 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
With the FDA recently resuming regular facility inspections, you can expect a spike in warning letters, import alerts and formal agency actions. This presentation will be invaluable in effectively engaging the FDA should you find yourself on the receiving end.
Meet Your Presenter
Steve Silverman is the president of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy and policy issues. Before forming The Silverman Group, he worked as vice president, technology and regulatory affairs, with AdvaMed, the leading medical device trade association. He also was a senior expert with McKinsey & Co., where he counseled pharmaceutical, medical device and other clients on regulatory strategies, product compliance and quality, and stakeholder communication.
Mr. Silverman’s professional experience includes nearly two decades in federal service, with extensive time in senior FDA roles, including as director of CDRH’s Office of Compliance and assistant director of CDER’s Office of Compliance. Mr. Silverman began his FDA work as an associate chief counsel, leading enforcement actions against drug and medical device companies.
Who Will Benefit
Mid-level staff and senior leaders across FDA-regulated medical product companies who interact with the FDA, including:
- Regulatory professionals
- Business leads
- Legal professionals
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Dec. 1, 2022