13 January 2012

Informa Life Sciences: Filing Variations in eCTD - conference 9 - 10 May 2012, Hotel le Plaza, Brussels, Belgium

Highlights of Filing Variations 2012 Conference

…at 2012’s evening seminar looking specifically at inter-agency discrepancies in filing variations. Dr. Keith Pugh (MHRA) and Rimas Jukanas (State Medicines Control of Agency of Lithuania) will examine the challenges faced by large and small regulatory authorities respectively.

…2012’s event features a case study focusing on experiences of grouping variations, followed by a panel discussion: How well is the work-sharing system working?

…hear how Pfizer, Sanofi AventisNovartis, and H. Lundbeck are ensuring filing variation success under the Variation Regulations

Beata Stepniewska of the European Generics Medicines Association will deliver in-depth feedback from their members on operating under the new guidelines

...Helle Ainsworth, Senior specialist in Regulatory Business Services at Lundbeck delivers practical insights and advice

·         Expert speaker Helle Ainsworth from Lunbeck demonstrates how to successfully submit a filing variation in eCTD

           To find more information about this event and Registration please use the below       mentioned weblink 

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