The course will cover the evolution of the registration systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency - Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005.
The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.
Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure.
Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described.
Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling medical devices and the Clinical Trial Directive.
This course will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in regulatory affairs.
Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
What You Will Learn
- European Union
- Decentralised Procedure
- Mutual Recognition Procedure
- National Procedure
- Key issues to consider for business opportunities
- Regulatory strategy
- Legal status of products and switching from Rx to OTC
- Medical devices legislation
- Clinical Trial Directive
Who Should Attend
Professionals in regulatory affairs, clinical research, project management, toxicology, product development and data management.
At the conclusion of this course, participants should be able to:
- Explain the registration procedures for filing applications for medicinal products in the European Union and recognise which routes are available for each product type (NCE, biotechnology, OTC and generic)
- Describe the concepts of global marketing authorisation and regulatory data protection
- Discuss the key issues that impact the choice of the registration procedure including trademarks and patents
- Describe the legislation effecting medical devices and procedures for obtaining Clinical Trial and Ethics Committee approval in Europe
Hotel & Travel
Kuechengasse 16, Postfach
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52