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Tuesday, September 28 • 11:30am - 12:15pm
REGULATORY UPDATE: FDA Inspections

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Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement
  • Identify recent trends in CDER-BIMO compliance and enforcement, including inspections of clinical investigators and sponsors
  • Evaluate what to expect during an inspection and how to best work with the FDA during the inspection
  • Describe key strategies for ensuring quality in clinical trials
  • Discuss approaches for responding to 483s and subsequent regulatory correspondence


Speakers
avatar for Miah Jung, Pharm.D., M.S.

Miah Jung, Pharm.D., M.S.

Acting Branch Chief, Compliance Enforcement Branch, Division of Enforcement and Postmarketing Safety, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, US FOOD AND DRUG ADMINISTRATION
Miah Jung is a lead pharmacologist in the Compliance Enforcement Branch (CEB), Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), FDA, and currently the acting Branch Chief in CEB. She has been with FDA for 9 years. In her work, she is responsible... Read More →


Tuesday September 28, 2021 11:30am - 12:15pm EDT