FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators

MessageThis Webinar is over
Date Nov 19, 2014
Time 01:00 PM EDT
Cost $149.00
Overview :
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Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Consistent with increased public attention to physician-industry ties and connections, the tone of the guidance suggests or infers that clinical trial sponsors should expect a more rigorous review by FDA of these financial arrangements. 

This Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA. The financial disclosure regulations in 21 CFR 54 are designed to help uncover potential investigatory bias that may arise due to financial ties between the investigator and the clinical trial sponsor. 

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the "draft" offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

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  • Review proposed changes to the 2011 released draft guidance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
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