ECA - GMP meets Regulatory Affairs

Art-No.: A-1063
Date: 24-25 April 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
13206Drug Approvals in the ICH countries: prerequisites and procedures0135
13207CTD: Module 1: Summary of product characteristics and other national requirements070
13208CTD Module 3 - Quality of the Drug Product: relevant GMP documents048
13209CTD Module 4 and 5: nonclinical and clinical documentation: GMP, GCP and GLP aspects067
13210Technical terms of GMP Inspections - EU-GMP requirements024
13211Quality without compromise040
13212Regulatory Compliance aspects during authority inspections046
13213CTD Module 3 - Quality of the Drug Substance: relevant GMP documents080
13214Handling variations and changes in the ICH countries051
13854What is a Regulatory Dossier015
14373Other GMP - Basics033

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