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Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.
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- Review proposed changes to the 2011 released draft guidance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All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including: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, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/2aa1gix
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