This training program (2 FULL days) will cover an in-depth discussion of Module 3 technical and scientific requirements as detailed in EMA & SAHPRA guidelines.

This training course introduces you to the Common Technical Document (CTD), as designed by the ICH (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). You will become more familiar with the  TECHNICAL & SCIENTIFIC REQUIREMENTS FOR: 

• CTD MODULE 3 (3.2.S/3.2.P/3.2.A/3.2R)

• &

• LINK TO ALL FORMS & MODULE 1

You will be given access to guidelines that specify in detail the structure of Module 3 of the CTD and the relationship between Modules and the documents that make up a dossier.