SBIA Webinar: Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment

SBIA Webinar: Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment

In this pre-recorded webinar, FDA discusses the new draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations - Questions and Answers, released in March 2019.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also reviews the importance of a risk-based approach to clinical trial monitoring and how to provide feedback on this draft guidance.  

* * Watch the Webinar HERE * *

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