Research and Markets has announced the addition of the "Variations to Marketing Authorisations in the EU" conference to their offering.
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
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.
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
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
13.30 Variations Workshop (Classification and Grouping)
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
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)
16.30 End of meeting
For more information about this conference visit http://www.researchandmarkets.com/research/w2pg2q/variations_to
View source version on businesswire.com: http://www.businesswire.com/news/home/20161005006216/en/Business Wire
Last updated on: 05/10/2016
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