klinicka praksa PhV

Good clinical practice shall mean a set of internationally recognised ethical and scientific requirements and quality assurance system which are used in designing, conducting, recording and reporting on clinical trials involving human subjects.


Inspection supervision is performed by competent inspectors for medicines for human and veterinary use as follows: pharmaceutical inspector in relation to medicines in the manufacturing, wholesale of medicines for human use, clinical trials of medicines, as well as application of guidelines of Good manufacturing practice, Good distribution practice, Good Pharmacovigilance Practice and Good Clinical Practice.

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