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Essentials and Overview of the Regulatory Framework in Europe




Nanterre, France


11 Jun 2018 - 12 Jun 2018

Reference No: D1802231 - DIA

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Key points about this Training Event

  • The European Regulatory Framework
  • EU Affairs
  • Marketing Authorisation for Human Medicinal products in the EU
  • Lifecycle Management
Event Description

Course Outline:

The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. Different steps and timelines for the various procedures will be covered. An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle. In addition, the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed

The course will cover the current registration systems available for approval of human medicinal products:

Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
Directive 2001/83/EC ‘the Community Code’ on the Mutual Recognition Procedures

A case study will enable participants to apply the freshly gained knowledge into their daily practice

This is a hands-on course
It is necessary that you bring your laptop/electronic device with you

At the conclusion of this course, participants will be able to:

  • Explain the European Regulatory Framework and registration procedures
  • Describe the concepts of marketing authorisation and regulatory data protection
  • Discuss the key issues that impact the choice of the registration procedure
  • Describe the lifecycle management

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained

When & Where?

11 June 2018 - 12 June 2018

Mercure Paris La Défense Grande Arche 17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot
92000 Nanterre (Paris region)


Course fee for members of DIA: €1450
Course fee for delegates : €1605

Group Discount available
Register 3 individuals from the same company and receive a 50% discount for a 4th

Applicant Requirements
  • Professionals with 1-2 years' experience in regulatory affairs, project management and product development
Reference No: D1802231 - DIA
DIA, a non-profit association, is the only global organization dedicated to bringing health care product development professionals together in a trusted, global, neutral environment to share insights and drive action in health care product development and life cycle management


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