International Drug and Device Recalls: Proactive Planning for FDA, WHO, EMA and Health Canada
Product Details
Drug and device makers are about to face the perfect storm.
A newly energized (and enforcement-focused) FDA. Multiple new international agency outposts. Commissioner Hamburg making supply chain-related issues priority No. 1.
It’s entirely possible that 2010 could be a record year for international recalls. 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.
Isn’t it about time you developed a proactive international recall strategy?
On Wednesday, March 24, you can begin to do so. Back by popular demand ...
International Drug and Device Recalls: the 90-minute FDAnews webinar that 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 upon 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 returns to share 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 March 24 webinar with all you need to successfully:
- Identify key variations in recall requirements throughout the world
- Build your own master global recall strategy based upon the regulations of the FDA, the World Health Organization (WHO), the European Medicines Agency (EMA) 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. From the comfort of your own office, 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
Wondering how you’ll retain everything in this fast-paced, 90-minute webinar? FDAnews has that problem solved ...
EXCLUSIVE WEBINAR BONUS |
With all that’s included, no wonder past attendees of this popular webinar weigh in favorably:
"It was well organized. The presenter was prepared and gave good verbal examples. Also liked the references cited on the FDA website."
Carol
Cernicky, QA Customer Complaint Supervisor, Gen-Probe Inc.
"Strong presentation and good fielding of questions."
Mark Stegner, Complaint Coordinator, GE Healthcare
Of course, Mr. Wood will be on hand to field your questions, too. Simply submit your questions via email, and you’ll have answers by the time the session ends.
And like every FDAnews webinar, International Drug and Device Recalls is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Better yet, one low registration fee per facility means you can sign up ten — or ten hundred — of your colleagues and never pay a penny more. (Who should you sign up? See “Who Will Benefit,” below, for recommendations.)
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.
Get your proactive international recall plan in place before it’s too late: attend James M. Wood’s repeat performance of International Drug and Device Recalls on Wednesday, March 24 — and claim your FREE WEBINAR BONUS: the complete, electronic playbook of specific, actionable strategies for global recall planning. Brought to you by FDAnews.