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Activity Number: 290 - Drug Safety Monitoring in a Complex World-Wide Regulatory Environment - Strategy Meets Methodologies
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329271 Presentation
Title: Quantitative Regulatory Landscape
Author(s): Lothar Tremmel*
Companies: CSL Behring
Keywords: safety monitoring; regulatory landscape; IND safety reporting; FDA; EMA

The global regulatory landscape for pre-market safety monitoring, periodic and expedited reports is evolving fast, driven by CIOMS and ICH as the major influencers. Recent trends include a shift in emphasis from single case analysis to aggregate analysis to identify safety topics, a shift from static analysis of safety to dynamic pre-marketing monitoring of aggregate data, and more focus on risk-benefit rather than considering safety in isolation. Despite ICH efforts in harmonization across the globe, important regional differences emerged that can be explained by different speeds in adopting these trends. We will give an overview over existing drug-safety related regulations and highlight trends and regional differences. Finally, we will emphasize how the shift from single case analysis to aggregate analysis can best be met by truly interdisciplinary teams with representatives from the medical as well as the quantitative professions.

Authors who are presenting talks have a * after their name.

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