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Essentials of European Regulatory Affairs

Jun 23 2014 8:00AM - Jun 24 2014 5:00PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

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Overview 

NEW OFFERING!

This is the must-attend training course for anyone needing to learn the essentials of European Regulatory Affairs - it has been extended to two days to include more topics, and it is kept up to date in minute detail by the experienced faculty.

The course will give an overview of the European regulatory system, 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. In addition the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the different procedures, the clock-stops, the compiling of questions etc.  

An introduction regarding the lifecycle will be given by information in respect to pharmacovigilance, variations and renewals.

The course will cover the curernt registration systems available for approval of 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
  • Decentralised procedure and referrals

What You Will Learn 

  • The European Network
  • Marketing Authorisation for Medicinal products in the EU
  • Lifecycle Management

Who Should Attend 

Professionals in regulatory affairs, project management and product development.

Learning Objectives 

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

  • Explain the European Network 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.

Hotel & Travel 

This course will take place at:

Hotel NH Musica

van Leijenberghlaan 221

1082 GG Amsterdam

The Netherlands

Tel: +31 20 79 56 088

E-mail: nhmusica@nh-hotels.com

 

DIA has blocked a limited number of rooms at the rate of EUR 122.00 per room/night, including VAT, excluding breakfast. To make the reservation, please click here.

Important: The room rate is available until 12 May 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

DIA Europe

 

Kuechengasse 16

4051 Basel

Switzerland

Tel: +41 61 225 51 51

Fax: +41 61 225 51 52

E-mail: diaeurope@diaeurope.org

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia Member
€710.00
Member Government
€710.00
Member Standard
€1420.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
Register Online

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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