Steps from Drug Development to Marketing Authorization

This page provides a proposed programme. Do you have any questions or require more information ? Please just send us an e-mail and indicate in the subject line your topic(s) of interest.

This is how your training course could look like:

08.30 - 08.45 Welcome
08.45 - 09.45 Phases in API and Drug Development
09.45 – 10.45 Clinial Trial Application and IMPD
10.45 – 11.15 Coffee Break
11.15 – 12.15 Marketing Authorisation Application and CTD
12.15 – 13.15 Lunch Break
13.15 – 14.15 Procedures for Marketing Authorisation Applications in the EU
14.15 – 14.45 Coffee Break
14.45 – 15.45 Quality Data in IMPD and CTD – What has to be provided?
15.45 – 16.45 How to deal with Changes/Variations
16.45 – 17.00 Final Discussion
ca. 17.00 End of Training Course

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GMP Conferences by Topics

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