The core aim of the draft guidance is to discover the financial linkage between the healthcare organization that carries out the clinical trial and the physician who is the source from whom the drugs get prescribed after they are successfully tested and approved. Towards this end, the FDA has set guidelines that require the stakeholders in a clinical trial to make declarations to the FDA about their financial interests. These are part of 21 CFR 54.
The way in which this draft is to be implemented will be the core of a valuable learning session from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Professionals can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=500833LIVE/~sel=LIVE/~David_Dills/~FDA’s_Guidance_on_Financial_Disclosure_by_Clinical_Investigators
David Dills, a highly experienced Global Regulatory Affairs & Compliance Consultant will be the speaker at this webinar. He will address the most pressing changes and discuss the issues that the FDA has received from industry and the public.
David will cover the following areas at this webinar:
o Review proposed changes to the 2011 released draft guidance
o Clarification on definition of sponsor
o Understand FDA’s clear actions that can and will be taken regarding refuse to file a marketing application
o Learn how to submit financial disclosure information to FDA
o Why FDA is expounding on due diligence and its significance
o Timing of data collection and purpose
o Understand how financial information should be disclosed to FDA
o Update regarding financial disclosure questionnaires
o Time period covered by regulations
o Clarification on covered clinical study
o Factors for FDA review of disclosed financial interests