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Monday, June 24 • 12:15pm - 1:00pm
#125 EE: ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)

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Component Type: Workshop
Level: Intermediate

FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this session the implementation plan for E2B(R2) IND safety reporting will be discussed in use case-based scenarios.

Learning Objectives

Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS); Describe several E2B R2 data elements, including regional elements that are key for premarket safety reporting.

Chair

Meredith K. Chuk, MD, MHS

Speaker

Facilitator
Suranjan De



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Monday June 24, 2019 12:15pm - 1:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA