Available Courses

Course 1: Drug and Device Development Regulation

2010 Will Solimene Award for Excellence in Medical Communication from the American Medical Writers Association (AMWA)

Course 1 is appropriate for professionals entering or already in the pharmaceutical, biotechnology, and medical device industry in the areas of nonclinical research, clinical research, drug safety and pharmacovigilance, project management, regulatory affairs, medical information or medical affairs, quality assurance/compliance. Course 1 is also appropriate for professionals in academic centers, healthcare practice settings, or in government organizations who are involved in drug, biologic, or medical device development.
More Info | Fact Sheet | Meet the Faculty

Course 2: Clinical Safety Surveillance

With interactive content and engaging, real-world case study exercises, this course covers what you need to know from a clinical trial sponsor perspective regarding the requirements and practice of safety data collection, assessment, and reporting of serious adverse events (SAEs) reports during clinical development. The course will help you understand the FDA and EU regulations and related ICH guidance documents pertaining to safety surveillance activities of an investigational product, or marketed product being investigated for a new indication, different formulation or new dose, as it moves through the various stages of clinical studies until licensed for marketing.
More Info | Fact Sheet | Meet the Faculty

Course 3: Postmarketing Pharmacovigilance

With interactive content and engaging, real-world case study exercises, Course 3 delivers key information on the receipt, evaluation, and reporting of postmarketing spontaneous adverse drug reactions (ADRs), including the procedures that marketing authorization holders/license holders must follow to fulfill US and EU regulations. Similarities and differences between postmarketing pharmacovigilance (PV) regulations in the US and EU are covered.
More Info | Fact Sheet | Meet the Faculty

Online drug safety training courses in BioSoteria’s eLadder™ Safety curriculum are:

• Available immediately through BioSoteria’s website—take any individual course or the full series from anywhere you have an Internet connection. No travel or classroom attendance required!
• Developed by an experienced multi-disciplinary team, including:
• A faculty of subject-matter experts and drug safety practitioners
• Instructional designers and medical writers who specialize in eLearning and the principles of adult learning
• Graphic designers, animators, and certified medical illustrators
• eLearning programmers and Learning Management System (LMS) specialists
• Content-rich and truly multimedia, with engaging graphics, animations, audio, photography, and immersive application and reinforcement exercises
• Self-paced—take the courses on your schedule: complete a section, exit the program, return the next day, and the Learning Management System tracks completion and bookmarks
• Engaging and easy to navigate—each course in eLadder Safety features intuitive navigation, allowing the learner to repeat content and course activities as often as needed
• Includes SafetyNOTES, a detailed, print-based study guide designed to accompany each course and serve as a content refresher and valuable future resource
• For the corporation seeking in-house drug safety training for their employees and contractors, BioSoteria’s eLadder™ Safety courses are also:
• Available off-the-shelf for rapid-deployment of drug safety training—no travel or customized development fees required
• AICC/SCORM-compliant and ready to run on a corporation’s Learning Management System (LMS). No LMS? No problem. BioSoteria offers a hosted LMS solution to deliver training to your employees and/or contractors.

Contact BioSoteria to learn more about our enterprise multi-user licensing options for companies.

THIS COURSE HAS BEEN APPROVED BY THE CALIFORNIA BOARD OF REGISTERED NURSING, PROVIDER #15586 FOR  CONTINUING EDUCATION CREDITS.

California Registered Nurses must retain this certificate for four years. Pharmacists may use courses approved by the California Board of Registered Nursing, towards their California continuing education requirement. (Section 1732.2(b) of the California Code of Regulations.)