Spring Intro 2023

24/03/2023

2021-03-01

The Regulation of Clinical Trials in Europe – An Agency Perspective

Gunilla Andrew-Nielsen Head of Clinical Trials Swedish Medical Product Agency (SMPA)

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LearningObjectives

• Clinical trials legislation

• Applying for authorisation to conduct a clinical trial o CTA Requirements o Assessment Process o Guidance

• Decentralised clinical trials

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