Pharmacovigilance in practice: Good Vigilance Practice
3250A
2025/26/1
Dr. Görbe Anikó
Experimentális és klinikai farmakológia
online
15
0
0
Teszt
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5
2025-09-18 08:45:00
'At the time when a medicinal product receives the first marketing authorization safety profile is not fully known due to the limitation of clinical trials. Safety information on real population therefore can be collected only after the medicine is introduced to the market. The purpose of pharmacovigilance is to ensure the positive benefit-risk ratio of drugs during post-marketing phase by collecting, assessing and communicating new information about available drugs. Undergraduate medical students learn the basics of pharmacovigilance which ensures that during every-day practice they are aware for the most important aspects of drug safety. However, for anyone who would like to contribute to, or work close to this field, needs to know the complete pharmacovigilance system in details. Good Vigilance Practice provides detailed guidance on different fields of pharmacovigilance about the expectations of a properly working safety surveillance system. It is also important to get oversight the cross-field areas like medical device, and cosmetics related vigilance along with the future challenges of drug safety and currently emerging solutions on the field. '
