Spring Intro 2023

Jenny Lamport

Notice to applicants volume 2B

 Harmonised view of Member States on how the legal requirements can be met

 No legal force ● latest version May 2008

https://health.ec.europa.eu/system/files/2016-11/ctd_05-2008_en_0.pdf

The Organisation for Professionals in Regulatory Affairs

7

Guidelines

CHMP

ICH

Safety

Quality

Efficacy Biotechnology Operational

The Organisation for Professionals in Regulatory Affairs

8

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