FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
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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 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Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.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This Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be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as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.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:
Who Will Benefit:
- Review proposed changes to the 2011 released draft guidance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
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
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.