BioSoteria Expands eLadder™ Safety Training Program With Launch of Postmarketing Pharmacovigilance Course

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BioSoteria, a drug safety and risk management consulting and training services provider, recently launched the third eLearning course in its comprehensive, innovative eLadder™ Safety Series

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

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

"Cousre 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.

eLadder Safety courses are:

  •     Available immediately online for purchase through BioSoteria's website or can be deployed on any company/institutional Learning Management System (LMS), allowing individuals to immediately access any course or the full core series, any time any place--no travel or time out of the office required
  •     Developed by an experienced, multi-disciplinary team, including: a faculty of subject-matter experts and experienced drug safety practitioners, eLearning instructional designers and medical education writers, graphic designers, animators, certified medical illustrators, eLearning programmers, and LMS specialists
  •     Self-paced, content-rich, and truly multimedia, with engaging graphics, animations, audio, and reinforcement exercises, including SafetyNOTES, a detailed, print-based study guide.
  •     Engaging and easy to navigate, each course in the eLadder Safety Program features intuitive navigation, allowing learners to repeat content and course activities as often as necessary

All three released eLadder™ Safety courses are available for corporate group license and individual purchase. To view a demonstration, visit To learn more, email training(at) today for a course demo and presentation on the entire eLadder Safety Training Program. Individuals may purchase and complete courses via the Internet through BioSoteria's website,

About BioSoteria
BioSoteria delivers high quality, innovative drug safety, pharmacovigilance, and therapeutic risk management consultant services and educational programs to the biopharmaceutical and healthcare community.

Our Mission statement:
BioSoteria is committed to client satisfaction and to providing its clients and strategic partners with comprehensive, knowledgeable, regulatory-compliant, cost-conscious recommendations for drug and medical product safety surveillance consultant services and training. Our commitment to patient safety and public health, as well as the education of medical product safety personnel, are hallmark to our corporate values and mission. We are dedicated to increasing the numbers of qualified medical product safety personnel in academic, governmental, and industry settings through our outreach to health care professionals (e.g., nurses, pharmacists, physicians) in clinical practice and to improving the skills and competencies of existing medical product safety personnel. These are the driving principles by which we conduct business and enter into collaborations with our clients and strategic partners.

For more information about BioSoteria and our services and educational programs, please email contact(at), visit our website at, or call +1 866-660-5553, ext. 13.

Michelle Flewell
VP, eLearning & Informatics
BioSoteria, Inc.
6425 Christie Avenue, Suite 220
Emeryville, CA 94608
1-866-660-5553 x013


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