Mastering EU Regulations on medications for human use

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Objectives

  • Learning European legislation on registration and maintenance of a pharmaceutical product
  • Understanding the different evaluations and registration processes
  • Understanding the content of a marketing authorisation dossier
  • Being able to understand a registration strategy and the decisions that need to be taken in advance

Audience concerned

Any employee involved in Pharmaceutical regulatory affairs

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Development of a medication
  3. European Regulatory Institutions
  4. Introduction to EU regulations on medications for human use
  5. Basics of a Marketing Authorisation (MA) Dossier
  6. Clinical trials in Europe
  7. Pharmacovigilance in Europe
  8. Maintenance of an MA dossier
  9. Scientific guidelines for medications for human use
  10. Study cases: pharmaceutical variations
  11. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CAAMM

Informations and registration : academy@caduceum.co.uk