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Conference Directory
FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: california
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Marketing & Sales, Clinical Affairs, 21 CFR 54, Clinical Investigation, Financial Disclosure, 2011 draft guidance, financial disclosure regulations, clinical investigators
Start Date of Conference:: 11-11-2011
End Date of Conference: 11-11-2011
Description of Conference: This webinar will help you understand FDA’s draft guidance on financial disclosure by clinical investigators and show how financial information should be disclosed to FDA.
Why Should You Attend:
Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators, 21 CFR 54. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.
Areas Covered in the Seminar:
- Review proposed changes to the 2011 released draft guidance.
- Clarification on definition of sponsor.
- Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
- Learn how to submit financial disclosure information to FDA.
- Why FDA is expounding on due diligence and its significance.
- Timing of data collection and purpose.
- Understand how financial information should be disclosed to FDA.
- Update regarding financial disclosure questionnaires.
- Time period covered by regulations.
- Clarification on covered clinical study.
- Factors for FDA review of disclosed financial interests.
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 9th November 2011.
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