International Drug and Device RecallsProactive Planning for FDA, WHO, EMA and Health Canada

Held Dec. 4, 2012

— Recall News Alerts —

Drugs: Recently, the FDA’s Office of International Programs (OIP) said it is exploring a single, global drug recall system that would encompass all domestic and international drug recalls.

Devices: Both CDRH and Health Canada plan to issue guidance soon on what evidence acceptably shows that a company’s recalls has been effective. These recall strategies are expected to document supply chain communications down to the patient.

No one can argue that it seems the FDA appears to be taking a tough stance on recall strategy. Are you ready?

Now, more than ever, you need a proactive recall strategy, one that includes the United States and every other country in which your products are sold.

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Like it or not — despite the complicated process you have to go through to receive regulatory approval — product recalls are a reality, in the U.S. and in every other country where your product is sold.

Those unprepared will see millions siphoned from their bottom lines — spent on everything from damage control advertisements to public relations experts — with countless man-hours wasted on spin control instead of new product development.

  Order today and you’ll get a complete, electronic playbook containing a specific,
comprehensive and actionable strategy for global recall planning.
It’s yours FREE with your order

International Drug and Device Recalls: the 90-minute FDAnews CD and transcript presentation shows you how to craft a master global recall strategy to protect your product from the toughest regulatory storms, at home and abroad — solidly based on the regulations of the FDA, World Health Organization, European Medicines Agency and the Health Protection Branch of Health Canada.

Noted attorney James M. Wood of Reed Smith shares with you his proactive, proven international plan for recalls — each step carefully developed from lessons learned in three decades representing manufacturers of prescription medicines and medical devices. You will complete this CD and transcript presentation with all you need to successfully:

  • Identify key variations in recall requirements throughout the world
  • Build your own master global recall strategy based on the regulations of the FDA, the World Health Organization, the European Medicines Agency and the Health Protection Branch of Health Canada
  • Apply the eight critical must-dos in product recalls
  • Select the members of your product recall team — who should be included and who should not (the answer may surprise you!)
  • Ensure recall team success with proven operating procedures and field-tested strategies
  • Learn risk-free — case histories give you a look at real-world recalls!

There’s more. International Drug and Device Recalls even gives you situation-specific advice on the “gray areas” of global recalls:

  • How you should handle mid-recall policy changes
  • How to allocate your resources during a recall in order to evaluate its effectiveness
  • When you must develop a proactive international recall strategy and how to do it
  • What role your attorneys and outside professionals should play during a recall
  • Where communication management fits in: what to say (what not to say), when to say it, how to gather the facts in preparation of communication and how to hire the right communications professionals

Mr. Wood has received rave reviews from prior FDAnews presentations, including:

"It was well organized. The presenter was prepared and gave good verbal example and gave me ideas on how to improve our recall process."

"Strong internal recalls presentation and good fielding of questions."

No company ever wants to face a recall. But recalls will happen — and an FDA “seal of approval” is no guarantee you’ll escape it.

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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

James M. Wood is a noted attorney with Reed Smith. His practice for 32 years has focused on the representation of manufacturers of prescription medicines and medical devices. He has represented and counseled manufacturers of prescription products involving a variety of issues. These have included recalls of prescription products, marketing and promotion of these products, First Amendment issues in marketing these products, off-label issues, preemption, product liability issues and the reuse of single-use medical devices.

Based on this experience, he has recently co-authored a book that details planning for and implementing the recall process for all regulated products, Prescription Product Recalls A Proactive Primer. He has also served as regional counsel for an international medical device company in a product liability action and was the multi-district litigation liaison counsel in the Gammagard® MDL litigation. 

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