FDA Enforcement

A new era in civil and criminal FDA Enforcement has begun.

Come to the one event which will guide you through the intricacies of the new regulatory requirements and compliance protocols for this new time of change and reform.

Proactively prepare for this seismic shift by attending the only event which will provide you with a comprehensive guide to the FDA’s civil and criminal enforcement policies, procedures, and priorities.

Dr. Hamburg has put the drug and device industries on notice – the FDA is accelerating enforcement actions with a fury not witnessed by regulatory and compliance professionals in over twenty years. The agency is implementing aggressive new enforcement protocols and compliance measures for which you must be well prepared.

Preeminent food and drug counsel and government enforcement experts will share insights they have gained from service at the highest levels of FDA and related agencies.

An expert speaker faculty of seasoned regulatory and compliance counsel will walk you through the core civil and criminal enforcement powers that FDA has at its disposal. They will prepare you for the rapidly evolving enforcement initiatives and help you anticipate and defend against future actions.

You will emerge from this conference with an in-depth understanding of the issues and proactive strategies which will enable you to:

• Formulate a fast, cost-effective, and comprehensive response to 483’s and warning letters
• Appreciate historic legislative changes by critically reviewing prior practices
• Develop protocols for inspection observations and violations fi ndings under the new guidelines
• Comprehend the scope of the FDA’s injunction and seizure powers, and cooperation with state and local authorities
• Implement strategies for increased international inspections, investigations, and multijurisdictional inquiries
• Gain insights into the criminal processes and procedures and how FDA and DOJ coordinate their investigations
• Prepare for a rise in Qui Tam actions in the wake of the 2009 False Claims Act Amendments

Also, don’t miss your opportunity to attend the post-conference Master Class on Drafting Strategies and Essential Elements for Every 483 and Warning Letter Response to FDA. This hands-on workshop will allow you to solidify your understanding of the 483 and warning letter process and help you develop comprehensive solutions for quickly and strategically responding to and negotiating with the FDA.

Meet these new challenges head-on in this evolving enforcement environment.

Learn to develop the essential strategies and solutions you’ll need to avoid the headlines. Register now by calling 888-224-2480 or online at AmericanConference.com/FDAEnforcement.

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