Start: 14.05.2012
End: 16.05.2012
London, United Kingdom
English
Delegates will gain a clear understanding of the current requirements for MA applications in the modular CTD format. Practical exercises will demonstrate the requirements for all parts of the dossier - quality, non-clinical and clinical. Delegates will acquire a good understanding of the changing regulatory requirements and procedures for Active Substance Master Files and Certificates of the European Pharmacopoeia. The use of electronic submissions will also be examined, together with the latest developments in Regulatory Affairs for EU Filings.
MWB Victoria, 10 Greycoat Place, Victoria, London, United Kingdom SW1P 1SB
The Booking Department
Informa UK Ltd
PO Box 406
Byfleet
United Kingdom KT14 6WL
+ 44 (0)2070177481
registrations@pti-global.co.uk
No date available