ComplianceOnline

FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators

Instructor: David Dills
Product ID: 702130
  • Duration: 85 Min

recorded version

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Read Frequently Asked Questions

This webinar will help you understand FDA’s draft guidance on financial disclosure by clinical investigators and show how financial information should be disclosed to FDA.

Course "FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators, 21 CFR 54. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.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This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be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.

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as well as invaluable insight into FDA’s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.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 Seminar:

  • Review proposed changes to the 2011 released draft guidance.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:

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.

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

Instructor Profile:

David R. Dills, an independent Regulatory & Compliance Consultant with more than 23 years of experience in the FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices covering a breadth of therapeutic areas 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 counsel on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files, addresses EU regulatory requirements regarding MDD and CE Mark and works with device registrations and approvals for the Pacific Rim, The Americas and EU.

He provides assistance during inspections and with post-inspection correspondence and meetings and enjoys responding to Regulatory Authorities regarding regulatory compliance and helping with a multi-country strategy. Background encompasses broad capabilities in quality management systems, regulatory affairs, GxP auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the device 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. Please refer to his profile provided herein for additional information about his background and areas of interest and expertise.

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