Spring Intro 2023

24/03/2023

Guidance

29

29

Sources of Guidance (1/3)

EudraLex – Volume 10 Clinical trials guidelines

Directive 2001/20/EC • Detailed guidance on the request to the competent authorities for

authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and declaration of the end of the trial (‘CT-1’)

30

30

15