FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
Date & Time: Thursday, October 13, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: David R. Dills
Price : $245.00
(for one participant)
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.
Areas Covered in the Session: l l l
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Review proposed changes to the 2011 released draft guidance Clarification on definition of sponsor Understand FDA’s clear actions that can and will be taken regarding refuse to file a marketing application Learn how to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
Click here to register for this webinar 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All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including: l
Clinical Affairs Investigators
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Quality and Compliance Marketing & Sales Distributors/Authorized Representatives
David R. Dills Industry Regulatory & Compliance Consultant, David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. ...more
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This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and wor...