ECA - The Regulatory Compliance Expert

Art-No.: A-1032
Date: 22-23 October 2013

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12973CTD: Module 1: Summary of product characteristics and other national requirements061
12974 CTD Module 2 - Quality of the Drug Substance: relevant GMP documents065
12975CTD Module 3 - Quality of the Drug Product: relevant GMP documents0146
12976CTD Module 4 and 5: nonclinical and clinical documentation: GMP, GCP and GLP aspects060
12977How to document drug substance quality: Certificate of Suitability (CEP) and Active Substance Master File (ASMF) in EU and DMF in US and Japan043
12978Regulatory Compliance aspects during authority inspections032
12979Peculiarities of drug approvals in Japan: GMP and quality related aspects055
12980Handling variations and changes in the ICH countries068

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