Event Date: 22/01/2010 01:00
The new European Variations Regulation (EC) 1234/2008 came into operation on 01 January 2010 and introduced a number of new concepts in the variation control of human and veterinary medicines. The IMB plans to extend the scope of this regulation in Ireland so that it applies to all marketing authorisation (PA) variations from the same date in principal, although the timelines for the EU procedures will not necessarily be followed initially and will be integrated as a later step.
What will be covered?
Topics to be covered include:
· EC Procedural Guideline
· EC Classification Guideline - conditions and documents requirements
· Type 1A immediate notifications
· How centralised, MR and National procedures will work
· CMD, BPG and new procedures involving CMD
· Handling of variations within the IMB
· Fees for variations
See agenda for more details and other topics covered.
To view and/or print presentations from the information day please see below.
1. New Variations Regulations - General Introduction
2. EC Procedural Guideline and Summary of main Procedural Changes
3. The EC Classification Guideline
4. CMD Best Practice (European aspect) on the new Variation Regulation
5. The role of the European Medicines Agency in the new Variations Regulations
6. Practical Advice on Submission of Variation Applications
7. Submission of Variations to the IMB
8. Fees for Variations under the new Regulation
Aims of the Seminar
While all the changes are founded on ‘better regulation’ principles, some of them are quite complex. The aim of the information day is to gain a detailed understanding of how the new classifications and procedures will work so that you can get the maximum benefit from the changes for your company and how the IMB will handle the new regulation from a practical prespective.
Who Should Attend
Representatives of the human and veterinary pharmaceutical industry and regulatory professionals with responsibility for the preparation and submission of variations to marketing authorizations for human and veterinary medicines. The emphasis will be on types of submissions and their requirements rather than on the detailed scientific data and assessment criteria.
Fee & Venue Details
The fee for this event includes course documentation, lunch & refreshments; €250 for this one day conference.
Venue: The Crowne Plaza Hotel, Northwood Park, Santry Demesne, Dublin 9
Times: Registration begins at 8.30am – 9.30am Presentation begins at 9.30am
Registration: Download the registration form.
Completed registration forms may be emailed to firstname.lastname@example.org
Or alternatively post/fax to:
Human Products Authorisation and Registration Department
Health Products Regulatory Authority,
Tel: +353 (0)1 6764971
Fax: +353 (0)1 6767836
Registration close off date is 15th January 2010.