FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: David R. Dills

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.

Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.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This Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be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as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.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:
- Review proposed changes to the 2011 released draft guidance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:
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

SPEAKER PROFILE:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

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