The course entitled “Post-authorisation stage of the product lifecycle” will explore the extensive list of responsibilities of Marketing Authorisation Holders (MAH) from the post-authorisation stage of medicinal products. Furthermore, it should be considered as a perfect introduction for the subsequent courses in the regulatory series. This course will give you a big picture of the wide array of regulatory activities, which are delivering in everyday work in regulatory affairs departments. Providing definitions and explanations to each activity together with the “real” examples, will help you to understand their meaning in context of medicines’ safety and regulatory compliance.
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Post-authorisation stage of the product lifecycle
Language: English 🇬🇧
Total Duration: 78 minutes
69.00€
About course
This course includes
48 minutes of Video Content
30 minutes of Course Practice Activities
Competence Test with 16 questions
Certificate after course completion
COURSE INSTRUCTOR
By attending this course, you will learn
- Explain the most fundamental MA principles
- List and describe the majority of responsibilities of MAH from the post-authorisation stage of the product lifecycle and understand their meaning in context of the medicines’ safety (renewals, variations, Art. 61(3) notifications, referrals, extension of MA, PV: post-authorisation safety updates; post-authorisation efficacy studies; availability of medicines (shortages notification); marketing status/cessation notification; sunset clause monitoring; MA transfers; post-authorisation measures (PAMs)
- Understand and describe what “the compliance” is and understand the impact of the compliance in everyday decisions of the regulatory professional
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