Variations to Marketing Authorisations in the EU

Variations to Marketing Authorisations in the EU, review of the Variations regulations. Update on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland).

Course Overview

Review of the Variations Regulations. Update 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.

Programme

09.00 Registration and Coffee

9.30 The Current Variations Regulations of the European Commission and procedures in Practice

  • Types of Variation
  • How to submit a Variation
  • Procedural and Practical Guidance
  • Processing timescales

Dr Patrick Salmon

11.00 Coffee

11.15 The Variations Regulations: the Industry view

  • Examples of current experience
  • Common reasons for invalid applications
  • Tips of working with the variation application form

Dr Anmar Marouf

12.30 Lunch

13.30 Variations Workshop (Classification and Grouping)

14.45 Tea

15.00 Clinical Variations

  • New indications
  • Extension of products into new patient groups
  • Supporting data and Expert Reports, including requirements for generic products
  • Amendments to safety information

Dr Patrick Salmon

13.45 Pharmaceutical Variations (chemicals, biologicals and biotech)

  • Type II variations versus line extensions
  • Variations involving the submission of Certificates of Suitability (CEP)
  • Drug Master Files
  • Quality Overall Summaries (Expert Reports)

Dr Anmar Marouf

16.30 End of meeting

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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Previous customers include...

  • Alcon Eye Care UK Ltd
  • Allergan UK Limited
  • Astellas BV
  • Bracco Imaging SpA
  • Catalent Pharma Solutions
  • Corporación Medichem, S.L.
  • Delaval NV
  • Diamond BioPharm Ltd
  • Forest Laboratories UK Ltd
  • Gilead Sciences Europe Ltd
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Gregory Fryer Associates
  • Grunenthal Ltd
  • Harefield Pharma Associates Limited
  • Ipsen Ltd
  • Lundbeck (Ireland) Ltd
  • Meda Pharmaceuticals Limited
  • NDA Regulatory Science Ltd
  • Pharmazet Group sro
  • Public Health England
  • Regional QC Laboratory
  • Rivopharm SA
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Ltd
  • Sandoz AG
  • Smith & Nephew Wound Management
  • Teva Pharmaceuticals Europe B.V.
  • Teva Sante
  • Voisin Consulting