FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators - Webinar By GlobalCompliancePanel

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Areas Covered in the Session:
Review proposed changes to the 2011 released draft guidance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
Who Will Benefit:
The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:
Regulatory Affairs
Clinical Affairs
Investigators
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Legal Counsel
Consultants