National dossier requirements and global life cycle management: How do they fit together? This course provides practical tips on how to professionalise your electronic dossier submission and life cycle management.
– eCTD requirements in Europe, the US and the ICH region
– Electronic submission requirements in LATAM, ASEAN, the Middle East and Africa
– Life cycle management: dealing with line extensions, new manufacturers, etc.
– Challenges of parallel submissions and splitting procedures
– Master data concept and core dossier
Vicente Tur, Scientific and Regulatory Affairs Director at Asphalion, will be speaking on Monday, 27 February!
Detailed programme here.