Course 1: Drug and Device Development and Regulation
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What will I learn?
After completing this course, you will be able to:- Compare the differing perspectives and goals of regulatory agencies and industry.
- Describe expectations for the safety of medical products.
- Identify the organizations and individuals who have a stake in the safety of medical products.
- Describe the roles and responsibilities of each stakeholder with regard to safety of medical products.
- Identify key events in the history of US regulation of medical products.
- Identify landmark legislation and describe its significance in regulatory history.
- Identify the phases of drug discovery and development.
- Describe the types of testing performed at each phase of development.
- Identify the regulatory milestones that occur during the development process.
- Identify the main regulatory agencies for the US, EU, and Japan.
- Describe the key regulatory documents and processes leading to marketing of drugs, biologics, and medical devices for the US and EU.
- Identify the leading organizations involved in efforts to harmonize global regulatory activities.
How long will it take to complete the course?
The course takes the average learner a minimum of 3 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 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.
Ready to register your drug safety department?
If you are interested in purchasing Course 1 or any course from the eLadder™ Safety eLearning Program for more than one user, multi-user licensing 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 (outside the US, please dial +1 650 616 4151).
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.
