Publication

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive

Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

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publication by

Stephan Reynier

Project Director

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive

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Sponsors of Clinical Trials in the EU/EEA – Call for Action!

Best ePRO practices – A patient centric approach

Getting an Early Access Program Off the Ground Safely

Are Registries the New “Gold Standard” ?

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive

Download the full publication now

publication by

More resources

Sponsors of Clinical Trials in the EU/EEA – Call for Action!

Best ePRO practices – A patient centric approach

Getting an Early Access Program Off the Ground Safely

Are Registries the New “Gold Standard” ?