Variations to Marketing Authorisations in the EU

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Review of the Variations on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland)

  • An introduction to the EC system for Variations
  • The Current Variations Regulations of the European Commission and procedures in practice
  • Review of latest requirements
  • Biologicals and Biotech
  • Pharmaceutical and Clinical Variations
  • Practical advice on the preparation and submission of Variation applications

WHY YOU SHOULD ATTEND

This meeting will give an introduction of the EC system for Variations with practical advice on the preparation and submission of Variation applications using the various European procedures.

There will be a review of experience with the latest Variation Regulations and of the available guidance on how they are being implemented.

WHO SHOULD ATTEND

The meeting is addressed to clinical and pharmaceutical personnel in the registration and regulatory affairs departments of the pharmaceutical industry, and all those involved in regulatory strategy for submissions to European markets.


Building:The Rembrandt Hotel
Address:11 Thurloe Place
CountryUnited Kingdom
Type:Seminar
Websitehttps://management-forum.co.uk/product/details/1769?referrer=lwsept16
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