Training Course, Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum (Aug 10 - 12, 2015)

This basic to intermediate-level course is based on the popular Premarketing Clinical Safety and Postmarketing Drug Safety and Pharmacovigilance Training Courses and focuses on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products in clinical trials, postmarketing studies, and under conditions of actual use in real-world health care settings. Late breaking regulatory changes, pertaining to the EU will be presented. Attendees will gain a detailed understanding of safety and pharmacovigilance obligations and best practices.