GMP-Seminare Regulatory Affairs

GMP meets Regulatory Affairs - Live Online Training

7/8 February 2023

GMP meets Regulatory Affairs - Live Online Training Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

API Regulatory Starting Materials - Live Online Training

9/10 February 2023

API Regulatory Starting Materials - Live Online Training

How to register APIs in Brazil - Live Online Training<br>

Tuesday, 28 February 2023 10.30 - 16.00 h

How to register APIs in Brazil - Live Online Training

Global Registration and Life Cycle Management of APIs - Live Online Training

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training Contents of the regulatory information in the ASMF and CEP

ICH Q8 Training Course - Live Online Training<br>

9/10 May 2023

ICH Q8 Training Course - Live Online Training
From QbD to Process Validation

Change Control (QS 13)

Heidelberg

23./24. Mai 2023

Change Control (QS 13) Von der Planung bis zur Umsetzung der Änderung

Drug Master File Procedures in the EU, the US and Japan

Vienna, Austria

6/7 September 2023

Drug Master File Procedures in the EU, the US and Japan Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

Handling Changes and Variations

Vienna, Austria

10/11 October 2023

Handling Changes and Variations

China GMP and Registration of APIs - Live Online Training

Thursday, 2 November 2023 13.00 - 16.30 h

China GMP and Registration of APIs - Live Online Training

GMP Seminare nach Thema