Course 3: Postmarketing Pharmacovigilance
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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.
This course will help you develop a clear working vocabulary and knowledge of the terminology and definitions of the specific US and EU regulations and guidance documents relevant to postmarketing pharmacovigilance of medicinal products.
What will I learn?
After completing this course, you will be able to:
- Understand the purpose and importance of postmarketing PV
- Know the US and EU regulations and guidance for postmarketing PV
- Discuss roles, responsibilities and relationships of internal and external stakeholders with regard to postmarketing PV
- Identify the sources of postmarketing safety reports and distinguish between spontaneous ADR reports and solicited AE reports
- Define the key terms and definitions pertaining to postmarketing PV
- Distinguish between serious and non-serious ADRs
- Distinguish between expected/labeled and unexpected/unlabeled ADRs
- Identify the steps that occur at the Drug Safety Department of the MAH/license holder after ADR report receipt
- Describe how ADRs are triaged and reported to regulatory authorities
- Describe the components of a complete case narrative
- Describe how to evaluate and report ADR reports from the literature
How long will it take to complete the course?
The course takes the average learner approximately 4 hours to complete. Note, you do not have to complete the course in one sitting. BioSoteria’s Learning Management System bookmarks and tracks your progress, allowing you to pace yourself through the material over time and repeat sections as often as you like.
Who should consider the course?
Course 3 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.
Ready to register your drug safety department?
If you are interested in purchasing Course 3 or any course from the eLadder™ Safety eLearning Program for more than one user, multi-user licensing at a discount is available. Contact us today to discuss the options available to you or your organization by emailing .(JavaScript must be enabled to view this email address), or call +1 (866) 660 5553 ext. 13 (outside the US, please dial +1 650 616 4151, extension 13).
Who developed the content for this course?
To guide content development, BioSoteria’s eLearning team carefully selects a Course Faculty of subject-matter experts who are currently practicing in the field of drug safety. This ensures that the content is accurate, current, and reflects the everyday realities of drug safety practitioners. Faculty members are integrally involved in reviewing course outlines, storyboards, and the course itself. Faculty members provide input into all facets of the course, including the content, graphics, and overall learning intent.
