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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)
Understanding Periodic Benefit-Risk Evaluation Reports
Tony Womack
INC Research, United States
Executive Director, Medical Writing
Continuous Benefit-Risk Analysis
Leonardo Ebeling, DrMed, PhD
Dr. Ebeling & Assoc. GmbH, Germany
Managing Director
Document-Specific, Role-Based Review Matrix
Gurparkash Singh, PhD
Janssen R&D LLC, United States
Principal Medical Writing Scientist
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