LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

• Authors: Katarzyna Syroka-Marczewska

Title variants

EN

LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

• Languages of publication: PL

Abstracts

EN

A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.

Keywords

EN

clinical trials; medicinal products; pharmacovigilance; pharmaceutical law

• Publisher: Katolicki Uniwersytet Lubelski Jana Pawła II
• Journal: Review of European and Comparative Law
• Year: 2017
• Volume: 28
• Issue: 1
• Pages: 67-84

Dates

published

2017-03-15

Contributors

author

Katarzyna Syroka-Marczewska

Identifiers

DOI

10.31743/recl.4312