San Bruno, CA (May 5, 2009) - BioSoteria, Inc. the leading West Coast provider of drug safety and risk management consulting and educational services, launched the second eLadder™ Safety course in the first-of-its-kind comprehensive, media-rich eLearning training series in drug safety and pharmacovigilance.
Course 2, titled “Clinical Safety Surveillance,” teaches the requirements and practice of safety data collection, assessment, and reporting of serious adverse event (SAE) reports during clinical development. With interactive content and engaging, real-world case study exercises, this course covers US and EU regulations and guidances, and ICH and CIOMS working group guidance pertaining to safety surveillance during drug and biologic development. Course 2 provides a step-by-step overview of the sponsor’s safety operations workflow, from receipt of SAE reports from investigators, through individual case safety report (ICSR) processing, including triage, data entry, writing case narratives, causality assessment, quality checks, medical review, and reporting to regulatory authorities, investigators, and Institutional Review Boards (IRBs)/Ethics Committees (ECs).
“We are very excited to be launching the next course in this first-of-its kind eLearning program focused on drug safety. Told from the clinical trial sponsor’s perspective, this interactive, comprehensive course provides drug safety, clinical research and regulatory affairs professionals with a solid foundational knowledge of clinical safety surveillance, firmly rooted in the realities of day-to-day safety operations,” said Sally Van Doren, President and Chief Executive Officer of BioSoteria.
eLadder Safety courses are:
• Available immediately online through BioSoteria’s website, allowing individuals to take any individual course or the full series—no travel required
• Developed by an experienced, multi-disciplinary team, including: a faculty of subject-matter experts and drug safety practitioners, eLearning instructional designers and medical education writers, graphic designers, animators, certified medical illustrators, eLearning programmers, and Learning Management System (LMS) specialists
• Self-paced, content-rich, and truly multimedia, with engaging graphics, animations, audio, and immersive application 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
Course 2: Clinical Safety Surveillance and other eLadder™ Safety courses are available for corporate group license and individual purchase. To learn more, email training@biosoteria.com today for a course demo and presentation on the entire eLadder Safety Training Program.
Individuals may also purchase and complete courses via the Internet through BioSoteria’s website, www.biosoteria.com/eLearning. To view a demo, visit www.biosoteria.com/elearningdemo.
The core curriculum series starts with courses 1 (Drug Development and Regulation) and 2 (Clinical Safety Surveillance), which are now available. Additional courses in the core eLadderTM Safety curriculum to be released throughout 2009 include the following: Postmarketing Pharmacovigilance, Premarket Annual Safety Reports, Postmarket Periodic Safety Reports, and MedDRA and WHODRUG Coding Conventions. Advanced courses will follow in pharmacovigilance, safety signal detection, risk-benefit analysis and therapeutic risk management, and other important topics to biopharmaceutical industry professionals.
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@biosoteria.com, visit our website at http://biosoteria.com/contact/, or call +1 866-660-5553 (+1 650 616 4151 outside the US).
