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Session 4: Safety Data Collection: Finding the Right Balance
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director
GSK, Canada
Today’s sponsors and regulators are faced with an increasing volume of safety data. This increase in volume often does not translate to a better understanding of the safety profile of a drug. Identifying ways to optimize safety data collection and reporting without compromising patient safety or regulatory compliance, can help alleviate the burden of managing safety data collected from various sources. In this session, various strategies in selective safety data collection will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe key elements of the new ICH E19 Guideline
- Recognize social media sources requiring close safety surveillance
- Outline important factors to consider when conducting literature searches
- Identify methods to help minimize unnecessary safety data collection while maintaining patient safety and regulatory compliance
Speaker(s)
ICH E19 Guideline – Optimization of Safety Data Collection
Fannie St-Gelais, PhD
Health Canada, Canada
Manager, Health Product and Food Branch
Adverse Event Data and Analyses: Toward a Value-Based Approach to Signal Detection and Management
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences