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Session 3: Updates on Polices, Guidances and Regulations – United States (U.S. Food and Drug Administration (USFDA)
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
This session will provide updates from the Office of Surveillance and Epidemiology (OSE) within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in recent advances in pharmacovigilance and risk management strategies including Risk Evaluation and Mitigations Strategies (REMS). It will discuss recent REMS Integration Use Case and Prototype Updates and the future vision for REMS integration with data standards. It also includes a review of the FDA Guidance: REMS Logic Model: A Framework to Link Program Design with Assessment Guidance for Industry.
Learning Objective : - Identify advances in FDA pharmacovigilance and risk management strategies, including REMS
- Describe recent REMS Integration Use Case and Prototype Updates, discuss the importance of the REMS data standard (HL7® US Medication REMS FHIR® Implementation Guide) publication, and describe the future vision for REMS integration with data standards
- Explain the purpose of FDA’s draft guidance and describe the three phases of the REMS logic model
Speaker(s)
Updates From the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER)
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
REMS Integration and Innovation Project Update
Edward Millikan, PharmD, RPh
FDA, United States
Senior Clinical Informatics Pharmacist, OMEPRM, OSE, CDER
A Review of the FDA’s Draft Guidance: Risk Evaluation and Mitigation Strategies (REMS) Logic Model
Victoria Sammarco, PharmD, MBA
FDA, United States
Risk Management Analyst
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