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Clinical Trial on Minors

Clinical Trial on Minors The protection of clinical trial subjects, the directive shall apply without prejudice to the national provisions…

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Manufacture and Import of Investigational Medicinal Product

Manufacture and Import of Investigational Medicinal Product The authorisation shall be required for both total and partial manufacture and for…

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Commencement Of a Clinical Trial

Commencement Of A Clinical Trial In starting a Clinical Trial, an application submitted by the sponsor and approval by the…

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Protection of Clinical Trial Subjects

Protection of Clinical Trial Subjects Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is…

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Legal Duties Of The Qualified Person

Legal Duties Of The Qualified Person The legal duties of the Qualified Person are defined in Directive 2001/83/EC, for marketed human medicines;…

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Clinical Trial Manufacture

Clinical Trial Manufacture This story and thinking behind that statement can be traced back to war crimes. During the Second…

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