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Session 2: Updates on Policies, Guidances, and Regulations – North America
Session Chair(s)
Scott Janiczak, PharmD, MPH
Safety Evaluator, LCDR, 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
Robert Ball, MD, MPH, MSc
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
FDA use of FMQs (FDA MedDRA Queries) and Standard Safety Tables and Figures
Y. Veronica Pei, MD, MEd, MPH
FDA, United States
Acting Associate Director, Biomedical Informatics and Regulatory Review Science
FDA Use of FMQs (FDA Medical Queries)
Scott Proestel, MD
FDA, United States
Senior Medical Officer, ODES, OND, CDER, FDA
Identification and Risk Management of Classic and Emerging DILI Phenotypes for New Drugs and Biological Agents: A Lifecycle Approach
Mark Avigan, MD
FDA, United States
Associate Director for Critical Path Initiatives, OPE, OSE, CDER
Pre-Market Challenges in DILI Risk Assessment and RM Approaches
Paul Hayashi, MD, MPH
FDA, United States
Associate Director of DILI, Division of Hepatology and Nutrition, OND, CDER
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