FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
e-Learning: Introduction to EU Marketing Authorisation
Introduction to EU Marketing Authorisation
e-Learning
2018-12-16 2018-12-16 an Ihrem Arbeitsplatz Online

e-Learning: Introduction to EU Marketing Authorisation

Principles, Procedures, Application Types and Maintenance

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...).
Topics
  • 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 distinguishes our event

5
Modules
24
Hour access to your personal learning environment on every day
2
Hours of learning content
6
controls of success

Aims and objectives

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.

Who should attend
Do you need basic regulatory affairs expertise since you already work in the pharmaceutical industry or plan to start working in this field? Then this e-Learning programme is the fast track to becoming knowledgeable in this field. No prior regulatory experience is required.
Your speaker
Dr. Christian M. Moers
Sträter Lawyers, Bonn, Germany


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