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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 key updates from the Office of Surveillance and Epidemiology (OSE) within the Center for Drug Evaluation and Research (CDER). It will focus on the REMS Integration Project Use Case and how it incorporates participant community feedback to inform iterative updates to the REMS integration prototype and present future updates to the REMS integration data standard. Additionally, the session will include an overview of the FDA’s draft Guidance on the REMS Logic Model, a framework designed to link REMS program design with assessment, offering valuable insights for the industry.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- Explain the purpose of FDA’s draft guidance and describe the three phases of the REMS logic model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)
Representative Invited
FDA, United States
REMS Integration and Innovation Project Update
Edward D. 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A Review of the FDA’s Draft Guidance: Risk Evaluation and Mitigation Strategies (REMS) Logic Model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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