Proactive Planning for Recalls:Developing a Global Strategy

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Alert: In 2008, the FDA recalled more products than ever before. CDRH recalled 2,472 products, 131 of which were Class I; CDER recalled 379 products with 36 being Class I products; and CBER recalled 2,070 products, 27 of which were Class I products. Each recall can result in millions of dollars spent on damage control, advertisements and public relations professionals. 

Product recalls are a reality, and an FDA “seal of approval” is no guarantee that your drug or device is in the clear. You need a proactive recall strategy — now!

Gain a thorough understanding of field-hardened strategies and eye-opening tips that can "make or break" product recall damage control, including:

  • Eight critical must-dos in product recalls
  • Five recall blunders to avoid
  • How to maximize resource allocation during a recall
  • What to say — and what not to say — when communicating during a product recall
  • Surprising advice on creating your product recall committee (including who shouldn't be on your team)
  • And more!

Sign up now for this comprehensive 90-minute Encore presentation and let noted attorney and author James M. Wood share his proactive plan for product recalls — developed from real-world lessons he's learned during more than 30 years of representing prescription medicine and medical device manufacturers on matters ranging from product recalls to off-label and liability issues.

This 27-Year-Old "Gold Standard" Case Can Improve Your Recall Strategy Today!

James also will examine the 1982 Tylenol case — considered to be the gold standard in product recalls — and highlight how this OTC recall can improve and inform your product recall planning today.

You'll take away specific, actionable advice that you can use immediately for your own product recall planning.

Sign up your entire team to listen in and discover how to:

  • Hand-pick the best product recall committee
  • Gather the right facts before you communicate during a product recall
  • Hire key communications professionals
  • Implement policy changes during a recall
  • Determine the roles played by attorneys and outside professionals during a recall
  • Properly time your product recall communications
  • Develop operating procedures for the product recall team

Don't wait until it's too late and then scramble to pull your product recall strategy together — and risk billions in lost profits and legal costs. Sign up for this proactive planning session today!

This presentation is a must for professionals in drug, biotech, biologic, device and diagnostics companies, along with drug/device wholesalers and distributors, including:

  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff
  • Media affairs
  • Executive management
  • General/corporate counsel

James M. Wood is a noted attorney with more than 30 years of experience representing both drug and device manufacturers. Through his practice, James has represented and counseled manufacturers of prescription products on a variety of issues, including prescription product recalls, off-label and product liability issues, preemption, the market and promotion of prescription products, and the reuse of single-use medical devices. Additionally, James served as regional counsel for an international medical device company in a product liability action and was the multidistrict litigation (MDL) liaison counsel in the Gammagard MDL litigation.

James also is the co-author of Recalls of Prescription Product: A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products.

Register now!

Date: Aug. 3–21, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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