From the Program

Introduction to chemical pharmaceutical documentation

Establishment of module 3 for MAA/MAV

Substance

3.2.S.1 General Information

3.2.S.2 Manufacture

3.2.S.3 Characterisation

3.2.S.4 Control of Drug Substance

3.2.S.5 Reference Standards or Materials

3.2.S.6 Container Closure System

3.2.S.7 Stability

ASMF och CEP

Product

3.2.P.1 Description and Composition of the Drug Product

3.2.P.2 Pharmaceutical Development

3.2.P.3 Manufacture

3.2.P.4 Control of Excipients

3.2.P.5 Control of Drug Product

3.2.P.6 Reference Standards or Materials

3.2.P.7 Container Closure System

3.2.P.8 Stability

Lecturers

Eva Ågren, AbcurAB/Advanz Pharma

Erik Hedner, Arex Advisor

Stefan Johnn, Kenvue

Ylva Hedberg, AstraZeneca