e-Learning: Introduction to EU Marketing Authorisation
Course
Online
Description
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Type
Course
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Methodology
Online
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Start date
Different dates available
This e-Learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties. - Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field. - This e-Learning was developed in May 2018.
Facilities
Location
Start date
Start date
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This centre's achievements
All courses are up to date
The average rating is higher than 3.7
More than 50 reviews in the last 12 months
This centre has featured on Emagister for 15 years
Subjects
- Marketing
- Communication Training
- ASEAN
- Regulatory
- Framework
- China
- Marketing Tools
- Marketing Processes
- Marketing Communications
- Safe
Course programme
- Module 2: Principles (The European Economic Area & the scope of Directive 2001/83/EC)
- Module 3: Procedures (MRP, DCP, CP, Referrals)
- Module 4: Application types (legal basis, CTD requirements, Generics, Herbals)
- Module 5: Post authorisation (Renewals, Sunset Clause, Variations)
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).
Additional information
e-Learning: Introduction to EU Marketing Authorisation