This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.
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Review proposed changes to the 2011 released draft guidance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All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:
Quality and Compliance
Marketing & Sales
David R. Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/2aa1gix
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