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