|Quantity Discounts||1 - 9999|
|1 - 9999|
|1 - 9999|
|1 - 9999|
Civil monetary penalties include:
Any person who fails to properly disclose trial information shall be subject to a civil monetary penalty up to $10,000. If a violation is not corrected within 30 days following notification − in addition to the above penalties – persons can be subject to penalties up to $10,000 for each day of the violation after such period until the violation is corrected.
If your trial is funded in any way by a federal agency, and you fail to properly disclose trial data, you could see your trial come to a grinding halt.
Section 801 of FDAAA allows for:
Any agency of the HHS, including FDA, NIH, or the Agency for Healthcare Research and Quality to withhold funding grants for trials currently in progress until disclosure requirements are met. And, the law allows government agencies to cut off future grants to companies or organizations that it feels are not in compliance.
If you aren’t 100 percent sure you are compliant in your reporting, this webinar encore presentation is a must-have tool to help you get on the right track.
Isn’t it about time you gained piece of mind over clinical trial disclosures?
In just 90 minutes, Barbara Godlew, clinical trial disclosure expert and president of FAIRE Consulting, delivers best practices for meeting the FDA’s expectations based on her extensive experience managing numerous pharmaceutical companies and academic medical centers.
This encore presentation is intended for anyone who wants to understand the legal requirements and tips and techniques to assure compliance. Stop worrying about clinical trial disclosure here and abroad.
Join Ms. Godlew as she conducts an encore presentation that focuses on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:
Like every FDAnews encore presentation, Clinical Trial Disclosure Compliance Strategies, 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.
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:
Barbara Godlew, RN, BA is the president of The FAIRE Company, LLC, and specializes in clinical trial disclosure consulting and medical writing. She is a recognized senior-level clinical trial disclosure expert and consultant for several major pharmaceutical companies and academic medical centers. She has worked with numerous small, medium, and large pharmaceutical, biotechnology, and medical device companies to assess and streamline their clinical trial disclosure operations, policies and processes. Ms. Godlew has authored numerous journal articles and has been an industry speaker about clinical trial disclosure issues. She is the recipient of the 2012 Drug Information Association Outstanding Service Award.
|Date:||Dec. 17, 2012 – Jan. 11, 2013
|Location:||Your office or conference room (no need to travel!)|
Gather your team for maximum benefit! Your investment is for one dial-in.
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