Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics: Overview of FDA Draft Guidance Issued for Comment– May 13, 2019
This on-demand webinar is FREE. It was recorded on May 13, 2019.
About this Webinar
In this webinar, FDA discusses the new draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics, released in May 2019. FDA will discuss why this draft guidance is needed, draft guidance content, and how to provide feedback on this draft guidance.
FDA Speaker
Lauren Milner, Ph.D.
Health Science Policy Analyst
Office of Medical Policy
Center for Drug Evaluation and Research (CDER)
FDA
Intended Audience
- Sponsors of clinical trials
- Contract research organizations
- Clinical trialists
- Foreign regulators
- Consultants servicing the clinical trial enterprise
- Regulatory affairs professionals
- Academia
Resources
- Draft Guidance: Submitting Documents Utilizing Real-World Data (RWD) and Real-World Evidence (RWE) to the FDA for Drugs and Biologics
- FDA-2019-D-1263
- FDA Real-World Evidence
- Framework for FDA’s Real-World Evidence Program
- Webinar: Framework for FDA’s Real-World Evidence Program - Mar 15, 2019
- An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies
Continuing Education
- This webinar is RAPS eligible for credit towards a participant’s RAC recertification.
- SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
- ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
Questions
For questions concerning the webinar, please contact CDER SBIA at: [email protected] or call (866) 405-5367 | (301) 796-6707
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