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Clinical Trial Approval in Europe

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...

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Investigator’s Brochure

The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...

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Good Practice – GxP

GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...

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Biosimilars

Biosimilars are medicines that are designed to be similar to previously approved biologic medicines.

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Personalised medicine

Stratified and personalised medicine involves tailoring treatments towards a specific group of patients or to individuals.

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