ISSN: 2041-6792

Clinical Investigation

Pharmacovigilance

 1.     The Pharmacovigilance Risk Assessment Committee (PRAC) is the main European Medicines Agency (EMA) committee which is responsible for assessing and monitoring the safety data on human medicines. The PRAC was established in 2012 with the Pharmacovigilance legislation to help strengthen the safety monitoring of medicines across Europe. It is responsible for the assessment of all aspects of risk management of human medicines which includes the detection, assessment, minimization, and communication of the risk of adverse reactions design and evaluation of post-authorization safety studies 3. Pharmacovigilance audit The PRAC also provides certain recommendations on questions on Pharmacovigilance and risk management systems and also including the monitoring of their effectiveness: Committee for Medicinal Products for Human Use (CHMP) for centrally authorized medicines and referral procedures. Coordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDH) on the use of a medicine in the Member States 3. The EMA secretariat, Management Board and European Commission, as applicable shows the basic responsibilities of PRAC.Annals of Pharmacovigilance & Drug Safety is an international open access journal in which we publish the articles regarding pharmacovigilance, drug safety. Allow access to the preprint PDF upon submission to processing for pharmacovigilance, there are few reports on manipulating free text patient information.  

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