2013 EU GCP Inspectors Working Group Workshop
14-16 October 2013, room 2A, EMA, London (UK)
7. Inspection of Statistical Aspects of a Marketing Authorisation Application (MAA)
7.1 Assessors’ review of the statistical aspects of a marketing authorisation (MAA) application. Ferran Torres, ES
7.2 How to look at practical aspects of statistical analysis whilst on inspection. Yolanda Barbachano, UK
BREAK OUT Session F–inspection of statistical analysis
Workshop presentation and additional material (requires password) go=>
Additional info:
GCP & Statistics: Good Statistical Practice (GSP) info
GCP & Data Management: Good Clinical Data Management Practice (GCDMP) info
Methodological & Statistical Guidances at EMA link
