Drug & Device Product Recalls

Jan. 14, 2011 - PRLog -- As companies respond to the heightened attention being paid by the FDA, Congress and the media to recent product recalls, it has become vital for industry professionals to increase their preparedness and be ready to develop tactical plans of action for risk assessment and management when future situations arise. We are now in a new, more litigious environment, with plaintiff attorneys mining recall statements for potential liability theories, and the government threatening to employ rarely used doctrines of corporate officer liability to go after individual life sciences executives. In response, industry counsel must learn how to work more in tandem with regulators, ensure that agency personnel are in receipt of appropriate information, and that they have the opportunity to provide the company with input. It is also now essential that companies know how to keep from opening the door to additional legal actions when they are drafting recall communications and other critical documents.

With every recall presenting unique challenges, ACI’s Summit on Drug and Device Product Recalls will bring together industry leaders who will share with you their proven strategies for determining when and how to execute one under complex and divergent sets of circumstances. The program faculty includes experts from Eli Lilly, Medtronic, Pfizer, Roche, Covidien, Integra LifeSciences and Genentech as well as distinguished legal and public relations professionals with detailed industry experience in managing and responding to recalls. They will show you how to expertly weigh the different risks and available options when a manufacturing issue or adverse event arises, and prepare you to develop an effective strategy for protecting your company’s brand and the public’s health. In addition, this event features special focus on how to meet the expectations of the FDA when performing a voluntary recall, and on increasing your company’s “recall readiness.” Valuable guidance and insights will be provided by Megan Lauff, Recall & Emergency Coordinator, FDA.

In light of the increasingly global focus of recent inquiries into industry practices, add value to your attendance by taking advantage of our interactive workshop, the Master Class on European Regulatory Handling of Adverse Events and Product Recalls. At this hands on high-level workshop, you will gain a deep understanding of how the FDA is working more closely with its European counterparts and how European processes need to be factored into international product recalls.
This industry-leading event will provide you with the strategies, tactics, and insights that are critical to protecting your brand. Don’t delay – register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online

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