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Wednesday, June 29 • 9:40am - 10:25am
#305: MedDRA: Use in the Review of New Drug Applications at the FDA

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Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will provide an overview of the use of MedDRA and Standardised MedDRA Queries in the review of New Drug Applications. It will include practical exercises designed to promote discussion of best practices and solutions to challenges in premarketing pharmacovigilance. Participants will gain a valuable insight into how FDA analyzes MedDRA data, with an emphasis on data quality.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Chair

David Richardson, MD

Speaker

Facilitator
Christopher Damian Breder



Speakers
avatar for Christopher Breder

Christopher Breder

Medical Officer, Office of New Drugs, CDER, FDA
Dr Breder is Medical Officer at the FDA with a focus on neurological disorders. He serves as the FDA Topic leader on the ICH team that maintains the MedDRA Points to Consider document. Prior to his employment at the FDA, Dr Breder served in several leadership roles in industry. He received his MD and PhD (Neuroscience) at the University of Chicago and completed his residency (Anesthesiology) and Clinical fellowship (Neuroanesthesiology) at The... Read More →
avatar for David Richardson

David Richardson

Owner, Richardson M.D. Consulting, LLC
David W. Richardson, M.D. is a drug safety/pharmacovigilance consultant, based in Atlanta, Georgia. Dr. Richardson is an adult neurologist; he attended Harvard College and University of Pennsylvania School of Medicine. He is a part-time consultant for the MedDRA Maintenance and Support Services Organization (MSSO). Dr. Richardson provides training services on behalf of the MSSO and also assists with the maintenance of MedDRA terminology. His... Read More →


Wednesday June 29, 2016 9:40am - 10:25am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA