e-Learning: Introduction to EU Marketing Authorisation

Course

Online

Price on request

Description

  • Type

    Course

  • Methodology

    Online

  • 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

Online

Start date

Different dates availableEnrolment now open

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Reviews

This centre's achievements

2020

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 1: Overview of the law and EU regulatory network
- 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

Medizinprodukte,Online Training,Online Weiterbildung,Pharma & Healthcare,Pharma / Medical devices

e-Learning: Introduction to EU Marketing Authorisation

Price on request