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Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations
Session Chair(s)
Reingart Bordel, DrSc, MS
Senior Manager Pharmacovigilance and Regulatory Affairs
Dr. Ebeling & Assoc. GmbH, Germany
The session will present the new structure of periodic safety update reports (PSURs)/periodic benefit-risk evaluation reports (PBRERs) according to the good pharmacovigilance practices (GVP)/ICH E2C(R2) guidance. Requirements and challenges for PSUR/PBRERs are outlined. Interference with RMPs and DSURs as well as practical advice for compilation is given. Examples for signal identification and risk evaluations are provided.
Learning Objective : Identify how to compile a PSUR according to the new EU and ICH guidance; Define the modular structure and to identify synergisms with, for example, RMP, DSUR, and CTD modules or sections, respectively; Recognize how to categorize potential and identified risks.
Speaker(s)
The Challenges of the New PSUR/PBRER Guidance and Strategies for Efficient Implementation
Steve Jolley, MA
SJ Pharma Consulting, LLC, United States
Chief Executive Officer
The New PSUR/PBRER: Template and Synergistic Workflows for the Continuous Benefit-risk Assessment During the Life Cycle of a Product
Reingart Bordel, DrSc, MS
Dr. Ebeling & Assoc. GmbH, Germany
Senior Manager Pharmacovigilance and Regulatory Affairs
PSUR/PBRER Submission Strategies and Special Requirements in the EU and the US
Sandra Hecker, RAC
Hecker & Associates, LLC, United States
US Agent; Regulatory Strategist for Clinical Trial and Marketing Applications
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