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Update on Postmarketing Safety Reporting
Session Chair(s)
Leonardo Ebeling, DrMed, PHD
Managing Director, Dr. Ebeling & Assoc. GmbH, Germany
Understanding Periodic Benefit-Risk Evaluation Reports
Learning Objective : Discuss a workflow to perform a continuous benefit-risk analysis in accordance with the Good Pharmacovigilance Practices; Describe a simple and effective solution to the review of clinical and regulatory documents; Discuss how outsourced PBRER reports add value to clinical development programs.
Speaker(s)
Tony Womack
Executive Director, Medical Writing, INC Research, United States
Understanding Periodic Benefit-Risk Evaluation Reports
Leonardo Ebeling, DrMed, PHD
Managing Director, Dr. Ebeling & Assoc. GmbH, Germany
Continuous Benefit-Risk Analysis
Gurparkash Singh, PHD
Principal Medical Writing Scientist, Janssen R&D LLC, United States
Document-Specific, Role-Based Review Matrix
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