This showcase will present the challenges in conducting drug safety and pharmacovigilance operations on a global basis and presents approaches to the harmonization of good pharmacovigilance practice across regions to accommodate many, if not most, regional requirements, while addressing specific local requirements. Safety and risk management practices in the EU, US, and Japan, including the new European pharmacovigilance legislation, are covered. Developed by the Clinical Safety and Pharmacovigilance (CSP) SIAC.

Learning Objectives:
Discuss global requirements for good pharmacovigilance practice
Explain the impact of the latest US and European regulations on international safety reporting and review methods
Describe the challenges for a Japanese company to comply with foreign safety regulations.