Steps from Drug Development to Marketing Authorization

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

Please note that we need about 3 months preparation for the organisation of your in-house training course.

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

Go back

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

Steps from Drug Development to Marketing Authorization

This is how your training course could look like:

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