October 29, 2021
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 universally recognised as a critical requirement for the ethical conduct of research involving human subjects. 1) The Directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they…
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October 14, 2021
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 human medicines; Directive 2001/82/EC, for marketed veterinary medicines and Directive 2001/20/EC for investigational human medicinal products. The legal duties of the Qualified Person, as defined in Directives 2001/83/EC (human medicines) and 2001/82/EC (veterinary medicines), are the…
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October 12, 2021
Clinical Trial Manufacture
Clinical Trial Manufacture This story and thinking behind that statement can be traced back to war crimes. During the Second World War, the Nuremberg Code was the most influential and widely quoted code, which originated in the so-called medical research carried out in the concentration camps. Part of the judgment at the “Doctors’ trial” at…
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October 5, 2021
Overview Of EU Law
Overview of EU law Europe as a society and union The European Union as an institution is neither a State nor an organisation. It is a union of states based on the rule of law and democracy. Each Member State delegates sovereignty over specific activities to common institutions that represent the interests of the Union…
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