Introduction to Global Medical Device Regulation (Synchronous e-learning)
About This Course
"This introductory course provides key foundational information related to the global regulation of medical devices with emphasis placed on ASEAN, EU and Asia-Pacific countries. Additionally, the role of the global regulatory professional will be examined in the context of these regulatory frameworks. Covering pertinent subtopics such as harmonization, ethics and legal perspectives, the course will prepare students for more in-depth examinations of submissions and the development of regulatory strategy.
1. To be able to understand the role of the Regulatory Profession and Professionals
2. To understand Medical Devices: Definition and Lifecycle
3. To understand the practice of Professional Ethics in Medical Device Regulation
4. To increase the students’ understanding of the critical role quality and compliance have in supporting good regulatory practices
5. Be able to work in a team
6. Be conversant in individual and group presentation and report writing.
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What You'll Learn
information related to the global regulation of medical devices with emphasis placed on ASEAN, EU and Asia-Pacific countries. Additionally, the role of the global regulatory professional will be examined in the context of these regulatory frameworks. Covering pertinent subtopics such as harmonization, ethics and legal perspectives, the course will prepare students for more in-depth examinations of submissions and the development of regulatory strategy."