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Changes in Regulations That May Impact How Inspections Are Conducted: Regulatory Perspectives
Session Chair(s)
Sherri Ann Hubby
Director, Clinical Quality Assurance
Vera Therapeutics, United States
Regulators will discuss changes in regulations that may impact how inspections are conducted by the FDA, EMA,and PMDA which will help sponsors, contract research organizations and study sites running clinical trials in the EU and internationally understand the important, updated compliance. Hot topics include new guidance for inspection of the electronic Trial Master File and e-Records, pre-inspectional activities, pre-announcements of inspections, inspectional risk criteria, similarities and differences in documents requested and reviewed, reportable observations as well as top inspectional findings as a result of the new guidance.
Learning Objective : Identify the current inspectional approaches of FDA, EMA, and PMDA; Explain how inspections link to decisions on application review and approval; Discuss the new EU clinical trial regulation and its impact on inspectional focus and regulatory advice regarding inspectional readiness of the electronic Trial Master File.
Speaker(s)
The Clinical Trial Regulation: A New Era for Europe
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
FDA Point of View
Cynthia Kleppinger, MD
FDA, United States
Senior Medical Officer, Office of Scientific Investigations, OC, CDER
PMDA Point of View
Naoyuki Yasuda, MSc
Pharmaceuticals and Medical Devices Agency, Japan