|Quantity Discounts||1 - 9999|
|1 - 9999|
|1 - 9999|
|1 - 9999|
With reports of industry “cherry picking” on the rise — and new rules currently in development — now’s the time to get expert guidance.
While the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH) ClinicalTrials.gov website, many are accused of cherry-picking and only reporting positive trial outcomes.
Yet, is it cherry picking or confusion on what constitutes an applicable clinical trial?
Regardless of your answer, the NIH, FDA and OIG are ramping up enforcement of the requirements and are increasing pressure on firms to report all applicable clinical trials. In 2010, three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements.
It’s a looming crisis for the clinical trials community. Fortunately, help is at hand.
Mark your calendar for Tuesday, Jan. 24, when Scott Cunningham conducts a webinar that focuses on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:
Like every FDAnews webinar, Registering Study Data on ClinicalTrials.gov 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 home office.
Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in clinical trials deserves to take part in this event — and they can do so at a cost that won’t break the budget. You only pay one low registration fee per facility, regardless of how many participate − so spread the word.
Why risk fines, penalties or worse, when preparing for these new reporting rules could be so painless? Don’t wait another minute.
Spread the word throughout your organization. Make particularly sure to notify the following key staff:
Scott Cunningham Esq is a partner at Covington & Burling LLP, where he is a member of the FDA practice group and both a frequent speaker and writer. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Mr. Cunningham graduated cum laude from the University of Pennsylvania Law School.
|Date:||Jan. 30 – Feb. 17, 2012|
|Location:||Your office or conference room (no need to travel!)|
Gather your team for maximum benefit! Your investment is for one dial-in.
Significant tuition discounts are available for three or more sites from
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