Proactive Planning for Recalls
Drugs and devices deemed safe by the FDA can still be removed from the market, with devastating results. (Merck stands to lose $29 billion in lost profits and legal costs alone from Vioxx.) 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
Order now for this comprehensive 90-minute audio CD/transcript, and let noted attorney and author James M. Wood share his proactive plan — developed from real-world lessons he’s learned during 30 years representing prescription medicine and medical device manufacturers, on matters ranging from product recalls to off-label and liability issues.
This 24-Year Old “Gold Standard” Case Can Improve Your Recall Strategy Today
James will also examine the 1982 Tylenol case — considered to be the gold standard in product recall — 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.
You will 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 role played by attorneys and outside professionals during a recall
- Properly time your product recall communications
- Develop operating procedures for the product recall team
- And more
Don’t wait until it’s too late, then scramble to pull your product recall strategy together — and risk billions in lost profits and legal costs. Order this proactive planning session today!
James M. Wood is a noted attorney with thirty years of experience representing both prescription medicine and medical device manufacturers. Through his practice, James has represented and counseled manufacturers of prescription products on a broad 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 multi-district litigation liaison counsel in the Gammagard® MDL litigation.
James is also the co-author of Prescription Product Recalls – A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products.
This audio CD/transcript is a must for positions 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