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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 4
First page : ( 1795) Last page : ( 1800)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00323.6

An Overview on Good Pharmacovigilance Practices and New Operational Plan Milestones of Eudravigilance in European Union

Narayanan A. S. Sathya*, Dr. Lakshmi K. S., Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: sathyaas96@gmail.com

Online published on 30 April, 2020.

Abstract

This review article mainly focuses on Eudravigilance (EV) the pillar for pharmacovigilance activities in the European Economic Area (EEA) which launched new operational plan for development of operational activity with anticipated timelines and also focuses on the Good Pharmacovigilance Practices (GVP) deals with analysis of safety data from uninhibited reporting systems with proven value for detection of risks of marketed medicines and with more modules of effected guidelines. EV system describes key activities and developments that will impact on or relate to itself and its stakeholders during the next 3 years from 2018 to 2020. The main aim is to ensure sustainability of EV and associated activities in support of the EU pharmacovigilance activities and protection of public health. The operational plan will be updated regularly as regards timelines and new activities/developments. In addition system interaction with the stakeholders as a part of training and communication engagement are covered to ensure that a platform for learning, cooperation and alignment throughout the evolution and operation of EV. GVP covers maintenance of risk management activities and to increase the beneficial effects of drug in population and maintenance of good reporting practices to avoid adverse reactions and the guidelines are based on population or product specific considerations and major pharmacovigilance process.

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Keywords

Eudravigilance, Good Pharmacovigilance practice, Pharmacovigilance, National competent authorities, Marketing authorization holders, European medicine agency.

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