Steps from Drug Development to Marketing Authorisation

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

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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