GMP-Seminare Regulatory Affairs

Name: Drug Master File Procedures in the EU, the US and Japan
Start: 2023-09-06
End: 2023-09-07
Location: 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)

Heidelberg

19. September 2023

Phytopharmaka Symposium 2023

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

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

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

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

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

Global Registration and Life Cycle Management for APIs

Barcelona, Spain

23-25 April 2024