ECA - GMP meets Regulatory Affairs

Art-No.: A-1063
Date: 21-22 May 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
13206Drug Approvals in the ICH countries: prerequisites and procedures070
13207CTD: Module 1: Summary of product characteristics and other national requirements076
13208CTD Module 3 - Quality of the Drug Product: relevant GMP documents - quality without compromise086
13209CTD Module 4 and 5: nonclinical and clinical documentation: GMP, GCP and GLP aspects068
13210Technical terms of GMP Inspections - EU-GMP requirements024
13212Regulatory Compliance aspects during authority inspections042
13213CTD Module 3 - How to document Drug substance Quality: DMF and CEP048
13214Handling variations and changes in the ICH countries052
13854What is a Regulatory Dossier016
14373Other GMP - Basics034

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