Clinical Research and GCP Update

Why a Regulation?

• Europe was losing share of research • “ensuring that the Union remains an attractive place for conducting clinical trials” (Whereas 8) • “simplify and harmonise “ (Whereas 4) • “Regulation shall be binding in its entirety and directly applicable in all Member States”. (A99)

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It’s here and it’s THE LAW. It’s “in-Force” now! (Since June 2014) Article99

But does not “ apply ” until ?2022?? More on this later!

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