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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information