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 Qualified Person The legal duties of the Qualified Person are defined in Directive 2001/83/EC, for marketed…
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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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Overview Of EU Law
Overview of EU law Europe as a society and union The European Union as an institution is neither a State…
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