The Regulatory Framework in Europe
Essentials and Overview of the Regulatory Framework in Europe
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.
What participants from previous course say:
"Comprehensive overview on EU regulations"
"This training is the best way to get a good overview on European Regulatory Affairs"
"Very interesting, useful and met all my expectations"
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 12.5 credits. Special rates available for SwAPP members.
DIA is an authorised training organisation accredited under the number 11 99 53383 75 to the Préfet of Ile-de-France.
What you will learn
- The European Regulatory Framework
- Marketing Authorisation for Human Medicinal products in the EU
- Lifecycle Management
Who should attend?
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