GMP-Seminare Regulatory Affairs

6/7 September 2022

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

Tuesday, 4 October 2022 13.00 - 16.30 h

China GMP and Registration of APIs - Live Online Training

Amsterdam, Netherlands

25 October 2022

ICH Q7 How to do – Hot Topics from the revised APIC Guidance - in Amsterdam or online A pre-conference session of the 25th APIC/CEFIC Global GMP & Regulatory API Conference

Amsterdam, Netherlands

26/27 October 2022

25th APIC/CEFIC Global GMP & Regulatory API Conference - in Amsterdam or online

15/16 November 2022

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

6/7 December 2022

Setting Specifications and Acceptance Criteria - Live Online Training

13. Dezember 2022

Stufenplanbeauftragte/r und QPPV - Live Online Seminar Pharmakovigilanz-Pflichten, Aufgaben und Verantwortlichkeiten

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

9/10 February 2023

API Regulatory Starting Materials - Live Online Training

Tuesday, 28 February 2023 10.30 - 16.00 h

How to register APIs in Brazil - Live Online Training