Quality Data in the Marketing Authorization Application

08.30 – 08.45 Welcome
08.45 – 09.45 Quality Data in CTD Module 2 and Module 3
09.45 – 10.45 CTD Modul 3 Quality Drug Substance – What is required?
10.45 – 11.15 Coffee Break
11.15 – 12.15 Advantage for the API Manufacturer (1): CEP
12.15 – 13.15 Lunch Break
13.15 – 14.15 Advantage for the API Manufacturer (2): ASMF
14.15 – 14.45 Coffee Break
14.45 – 15.45 CTD Module 2: Quality Overall Summary
15.45 – 16.30 QP-Declaration in CTD Module 1: Auditing API Manufacturers
16.30 – 17.00 Final Discussion
ca. 17.00 End of Training Course

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