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European Regulatory Affairs: In-depth review of current registration procedures in the European Union

Nov 28 2013 12:30PM - Nov 29 2013 4:00PM | Mercure Paris la Villette 216 Avenue Jean Jaures 75019 Paris France

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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
  • Centralised Procedure
  • 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.

Learning Objectives 

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 

Contact Information 

DIA Europe
Kuechengasse 16, Postfach
4002 Basel

Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org


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Registration Fees 

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Charitable Nonprofit/Academia Member
Member Government
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Charitable Nonprofit/Academia Nonmember
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NonMember Standard
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CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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