Steve has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 80 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England.
Dr. Van Doren has over 22 years of industry clinical development, drug safety and risk management experience, has headed safety departments in several companies and is currently President & CEO of BioSoteria, a drug safety consultant services company.
Drug Safety & Pharmacovigilance expert. EWG for ICH E2D, and Rapporter for ICH E2D. Lecturer of many educational seminars.
Description
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.