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Bethesda North Marriott Hotel and Conference Center

2023 年 02 月 06 日 1:00 下午 - 2023 年 02 月 09 日 12:35 上午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 3: FDA Safety Regulatory Updates

Session Chair(s)

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER

FDA, United States

Jamie Ridley Klucken, PharmD, MBA, RPh

Jamie Ridley Klucken, PharmD, MBA, RPh

Safety Evaluator, Division of Pharmacovigilance, OSE, CDER

FDA, United States

In this session, FDA representatives within the Center for Drug Evaluation and Research (CDER) will provide updates on Risk Evaluation and Mitigation Strategies (REMS) from the Office of Surveillance and Epidemiology (OSE); updates on FDA draft guidances on the Benefit-Risk Assessment for New Drug and Biological Products for Industry (September 2021), and on Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (June 2021); and updates from the FDA’s Premarketing Safety Assessment Working Group on FDA Medical Queries (FMQs) from the Office of New Drugs (OND).

Learning Objective :
  • Identify advances in pharmacovigilance and risk management strategies, including REMS
  • Examine the FDA assessment of emerging safety signals and review of safety data
  • Discuss FDA draft guidances on benefit-risk assessment and safety reporting for IND bioavailability/bioequivalence studies
  • Describe FDA MedDRA Queries and standard safety tables and figures

Speaker(s)

Gerald  Dal Pan, MD, MHS

Speaker

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Sara L. Eggers, PhD

Speaker

Sara L. Eggers, PhD

FDA, United States

Director, Decision Support and Analysis Team, OSP, CDER

Alyson  Karesh, MD

Speaker

Alyson Karesh, MD

FDA, United States

Director, Division of Clinical Trial Quality, Office of Medical Policy

Scott  Proestel, MD

Speaker

Scott Proestel, MD

FDA, United States

Senior Medical Officer, ODES, OND, CDER, FDA

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