BioSoteria Expands eLadder™ Safety Program With Launch of Postmarketing Pharmacovigilance Course
Emeryville, CA (June 30, 2009) - BioSoteria, Inc. the leading West Coast-headquartered provider of drug safety and risk management consulting services and training, launched the third course in the eLadder™ Safety series. This course expands the core offerings of this first-of-its-kind comprehensive, media-rich eLearning training series in drug safety and pharmacovigilance.
Course 3: Postmarketing Pharmacovigilance delivers key information on the receipt, evaluation, and reporting of all sources of postmarketing adverse drug reactions (ADRs), including the procedures that marketing authorization holders must follow to fulfill US and EU regulations. Similarities and differences between postmarketing pharmacovigilance (PV) regulations in the US and EU are covered in detail, as well as several case studies to illustrate and simulate the handling of real life reports.
Course 3 was developed by the eLadder Safety Instructional Design/eLearning team, who worked in concert with a multidisciplinary Course Faculty of seasoned pharmacovigilance practitioners, including:
Lauret I. Ballsun, RN, BSN, Principle, LBC Pharmaceutical Professionals, LLC
James Buchanan, PharmD, Senior Vice President, Pharmacovigilance and Risk Management, BioSoteria, Inc.
Brian Edwards, MD, Director of Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd.
Dana Lee, PharmD, Senior Director, Pharmacovigilance, Amylin Pharmaceuticals
Penny Wilkins, PharmD, Director of Drug Safety Genentech
“Course 3 is one of three comprehensive, online eLadder Safety course series now available, starting with Course 1: Drug and Device Development and Regulation, Course 2: Clinical Safety Surveillance, and now Course 3: Postmarketing Pharmacovigilance,” said Sally Van Doren, President and Chief Executive Officer of BioSoteria. “Together, these courses offer a convenient, cost-effective, full lifecycle approach to drug safety training, and serve as the foundation to more advanced course offerings to be launched later in the year,” she said.
