CTD Dossier Requirements Focus on EU Module 1 and Quality Module 3

Venue: Scitech Centre

Location: Mumbia, India

Event Date/Time: Mar 21, 2010 End Date/Time: Mar 22, 2010
Report as Spam


This Module provides a comprehensive description on the Common Technical Dossier structure —
completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course is
focusing on the specific regional EU requirements for Module 1 including discussion of the relevant
legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail,
taking into account the recent ICH-Q guidelines.