9th International Conference and Exhibition on Pharmacovigilance & Drug Safety
RegPak BioPharma Consulting, Netherlands
Title: Good pharmacovigilance practice
Biography: Parminder Kaur
Effective pharmacovigilance requires a set of rules, operating procedures, and practices that must be followed to ensure the quality and integrity of marketed product. Good Pharmacovigilance Practice (GVP) is a quality standard for monitoring the safety of medicines and if necessary, taking action to reduce the risks and increase the benefits of medicines. It ensures the detection, collection, assessment, understanding, and prevention of adverse effects with medicinal products. As per GVP, every Marketing Authorization Holder (MAH) must ensure that they have an adequate and effective quality system for monitoring the medicines they have license for. It is expected that MAH: maintains a pharmacovigilance system; document all actions they take concerning safety reporting and signal detection and; have enough competent, appropriately qualified and trained staff to work the system. In order to gain a greater understanding of GVP requirements, this session will cover GVP modules I to XVI covering major pharmacovigilance processes which should be implemented by the pharma companies doing business in EU.