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Pharmacovigilance and Risk Management Strategies Conference
Session 8: Reference Safety Information Use in Clinical Trials
Session Chair(s)
Stephen Knowles, MD, MRCP
- Chief Medical Officer
- Halozyme Therapeutics, United States
Michael Richardson, MD, FFPM
- International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
- Bristol-Myers Squibb, United Kingdom
The regulatory expectations in Europe on the use of the RSI to assess expectedness in clinical trial cases has led to challenges for companies in implementing the guidance on the RSI and has led to critical and major findings in EMA regulatory inspections. Regulatory guidance, including updates to previous guidance, and examples of inspection findings will be presented.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the requirements for the use of the RSI in clinical trials
- Understand how the requirements are enforced by regulatory agencies
- Learn some approaches that have been successful
Speaker(s)
Speaker
Andrea Best, DO, MPH
- Executive Medical Director
- AbbVie, Inc., United States
Status of the CTFG Q&A-RSI Implementation From a Regulatory Prospective
Elena Prokofyeva, MD, PhD, MPH
- Head of Drug Safety Unit, Department of Research & Development, DG PRE
- Federal Agency for Medicines and Health Products (FAMHP), Belgium
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Pharmacovigilance and Risk Management Planning
Short Course 2: Interdisciplinary Safety Evaluation During Product Development
Short Course 3: Reference Safety Information
Short Course 4: Introduction to Statistics in Pharmacovigilance
Short Course 5: Pharmacovigilance for Medication Errors
On Demand Content Preview Webinar
Preparing for PV Inspections – Beyond the Basics
Download eBook
Pharmacovigilance and Risk Management in 2020: A Global Perspective