Online Training 2016 - FDA's 2011 Guidance on Financial Disclosure by Clinical Investigators - By Compliance Global Inc

Overview
This webinar will provide an overview and FDA guidance to firms that are either going through or preparing to go through clinical trial training and working with clinical investigators.
In Spring 2011, FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigator training. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.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.
Why Should You Attend
This Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure regulations to be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 arrangement between the investigator and the clinical trial sponsor.
Areas Covered in this Webinar
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as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.
Learning Objectives
Review proposed changes to the 2011 released draft guidance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
Regulatory Affairs Personnel
Clinical Affairs Personnel
Investigators
Quality and Compliance Professionals
Marketing & Sales Professionals
Distributors/Authorized Representatives
Legal Counsel
Consultants
Speaker Profile
David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory 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 on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR's and demonstrates credible experience to maximize business performance in the devices arena.
He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones.
David has been previously affiliated with well-known device manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals.
Level
Beginner
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