What makes 2012 unmissable? - 13 industry presentations delivered by regulatory experts from leading pharmaceutical companies
- 9+ hours of netiling Variations is a course that covers topics such as:
- Variations procedures
- Variations revisions
- The impact of the CTD on Variation dossier
- Submitting Variations on time with the right supporting data
- Variation procedures for international applications
- Collect and present complete information on Variations
- The challenges of type II Variations under the MRP
Filing Variations 2012 brings together Personnel from Dossier registration department, Regulatory Affairs, Application/ Registration, Product Information, RA compliance and other disciplines who have an impact on the process of filing Variations.
- Practical advice on how to determine implementation dates, use annual reporting and manage a variation in eCTD.
- Industry case studies examining experiences of the 1234/2008 guideline including overcoming the hurdles of grouping variations and worksharing
- Learn how to use the article 5 procedure and handle variations via the MRP procedures
- Expert advice on how to prepare for the implementation of article 57 and XEVMPD
