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Webinar: Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment

SBIA Webinar 2016

In this webinar, FDA discusses the new draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations - Questions and Answers, released in March 2019. FDA will also review the importance of a risk-based approach to clinical trial monitoring and how to provide feedback on this draft guidance. 

Recorded on April 1, 2019.

 

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Speaker

Ansalan Stewart, Ph.D.
Health Science Policy Analyst
Division of Clinical Trial Quality
Office of Medical Policy (OMP) | Center for Drug Evaluation and Research (CDER) | FDA

Intended Audience

  • Sponsors of clinical trials
  • Contract research organizations
  • Clinical trialists
  • Clinical trial site staff
  • Foreign regulators
  • Consultants servicing the clinical trial enterprise

Questions

For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
 

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