Variations to Marketing Authorisations in the EU

Management Forum

Short course

In The Rembrandt Hotel, London

£ 699 + VAT

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Description

  • Type

    Short course

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Duration

    1 Day

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

Facilities

Location

Start date

The Rembrandt Hotel, London (London)
See map

Start date

On request

About this course

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.

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.

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Reviews

Subjects

  • Marketing
  • Regulations
  • Management
  • Medical Devices
  • Medical training
  • Variations
  • Pharma
  • Pharmaceutical Management
  • Intellectual Property
  • Legal expertise

Teachers and trainers (2)

Dr Anmar Marouf

Dr Anmar Marouf

Scientific Director at Inresa Arzneimittel GmbH, Freiburg, Germany.

Dr Patrick Salmon

Dr Patrick Salmon

Irish Medicines Board

Course programme

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.

See related categories

Variations to Marketing Authorisations in the EU

£ 699 + VAT

The best International Law courses

See all

See all