GMP-Seminare Regulatory Affairs

5/6 October 2023

ICH Q12 Training Course - Live Online Training How to use the PACMP in Practice

Vienna, Austria

10/11 October 2023

Handling Changes and Variations

Berlin, Germany

24 October 2023

Pre-Conference Session to the 26th APIC/CEFIC Global GMP & Regulatory API Conference - in Berlin or online GMP approaches for your day to day API work

Berlin, Germany

25/26 October 2023

26th APIC/CEFIC Global GMP & Regulatory API Conference - in Berlin or online

Thursday, 2 November 2023 13.00 - 16.30 h

China GMP and Registration of APIs - Live Online Training

5/6 December 2023

Setting Specifications and Acceptance Criteria - Live Online Training How to Achieve Regulatory Compliance for APIs, Biological Substances and Drug Products

Munich, Germany

20/21 February 2024

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

Munich, Germany

22/23 February 2024

API Regulatory Starting Materials Definition, Manufacture, Assessment and handling post-approval Changes

Tuesday, 27 February 2024 10.30 - 16.00 h

How to register APIs in Brazil - Live Online Training
Focus on CADIFA and obtaining a Brazilian GMP certificate

10/11 April 2024

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

Barcelona, Spain

23-25 April 2024

Global Registration and Life Cycle Management for APIs

Mannheim

15./16. Mai 2024

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