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Update on Postmarketing Safety Reporting

Track:
Medical Communication, Medical Writing, and Medical Science Liaison

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
236

Room Number:
30AB

Level:
Intermediate

Type:
Session

Title:
Update on Postmarketing Safety Reporting

Chair(s):
Leonardo Ebeling
Dr. Ebeling & Assoc. GmbH, Germany

Description:
This session will outline periodic benefit-risk evaluation reports (PBRER) requirements, how they are prepared and why, review the requirements and setup of a PBRER report, describe a simple and effective solution to the review of clinical and regulatory documents, and discuss the benefits and efficiencies that can be gained by outsourcing this service.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Understanding Periodic Benefit-Risk Evaluation Reports
Tony Womack
Executive Director, Medical Writing
INC Research, United States

Continuous Benefit-Risk Analysis
Leonardo Ebeling
Dr. Ebeling & Assoc. GmbH, Germany

Document-Specific, Role-Based Review Matrix
Gurparkash Singh, PhD
Principal Medical Writing Scientist
Janssen R&D LLC, United States