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Session 2: Updates on Policies, Guidances, and Regulations – North America
Session Chair(s)
Scott Janiczak, PHARMD, MPH
Team Leader, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
Joseph Paradis, PHARMD
Associate Director for Medication Error and Risk Management Initiatives, CDER, FDA, United States
Robert Ball, MD, MPH, MSC
Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Session 2: Updates on Polices, Guidances and Regulations – North America
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe recent FDA updates regarding pharmacovigilance and risk management strategies and assessing safety signals
- Describe the use of FDA FMQs (FDA Medical Queries) and Standard Safety Tables and Figures
- Recognize post-market aspects of DILI risk assessment and RM approaches that aid in reporting data to the FDA
Speaker(s)
FDA Updates for Pharmacovigilance
Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
FDA use of FMQs (FDA MedDRA Queries) and Standard Safety Tables and Figures
Deputy Division Director, FDA, United States
FDA Use of FMQs (FDA Medical Queries)
Principal, Bethesda Pharmaceutical Consulting, LLC, United States
Identification and Risk Management of Classic and Emerging DILI Phenotypes for New Drugs and Biological Agents: A Lifecycle Approach
Associate Director for Critical Path Initiatives, OPE, OSE, CDER, FDA, United States
Pre-Market Challenges in DILI Risk Assessment and RM Approaches
Associate Director of DILI, Division of Hepatology and Nutrition, OND, CDER, FDA, United States
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