This comprehensive three-day program will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, how to optimally utilize epidemiological, clinical pharmacological and other techniques, risk management strategies, and how to create an effective organizational “system.” Session topics will include:
- Latest international regulatory developments
- How to generate and assess critical safety data during development
- Compliance with clinical safety and post-marketing pharmacovigilance regulatory requirements in an evolving global environment
- Recent multinational initiatives under the International Conference on Harmonization (ICH) and Council for International Organizations of Medical Sciences (CIOMS) on Drug Safety Update Reports (DSURs) in premarketing clinical trial safety
- New approaches to risk management, risk communication, labeling and packaging to optimize medical product benefit while minimizing preventable harm
Pre-conference tutorials on January 9 will focus on:
- Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art
- Periodic Safety Update Reports (PSUR): A Guide to the Construction and Analysis of PSURs, ASRs, and DSURs
- Applied Epidemiology Techniques for Pharmacovigilance Risk Management
- Applying MedDRA® in Clinical Safety, Pharmacovigilance and Labeling
- Pharmacovigilance and Risk Management Planning