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Data management in pharmacovigilance
Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 20 3868 9735

Data management in pharmacovigilance


International Conference on Clinical Trials

July 27-29, 2015 Orlando-FL, USA

Ajay Francis Christopher

ScientificTracks Abstracts-Workshop: J Clin Trials

Abstract :

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection,
evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. In 1893,
The Lancet first reported an established drug safety reporting system for suspected adverse drug reactions (ADRs). Since then, the
definition and scope of pharmacovigilance have evolved as a systems approach. Pharmacovigilance is a highly sensitive field as it
involves monitoring of the safety of medicines and taking action to reduce risk and increase benefit. The pharmacovigilance data
management starts with the data collection and, it is imperative to address the report origin, triage cases, enter information in drug
safety database, make medical assessment, request report follow-up information and mode for regulatory submissions. All these
stages require a high and complex degree of technical skill and judgment to ensure that accurate conclusions and right decisions
are made during the establishment of benefit-risk profile for a product. A poor pharmacovigilance data management not only
jeopardizes patient safety, it also increases the risk of investing in the development of wrong product which causes a huge loss to a
pharmaceutical company. Therefore, it is very important to establish a robust pharmacovigilance data management system which
complies with the stringent regulatory guidelines, global pharmaceutical norms and ultimately safeguard the pharmacovigilance
end users, the patient. An ideal model would be implementation of business management software (e.g. Microsoft Dynamics NAV/
SAP ERP) for better data management, process harmonization, enhanced data security and reduction in delay due to high manual
dependence.

Biography :

Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality Scientist and
Subject Matter Expert-PVQA for blue-chip pharmaceutical companies at a premier CRO in India. He has one Young Scientist Award and various appreciation
awards to his credit. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation
of Oracle Argus Safety 5.0.2, etc). He has published and presented research articles on microRNA expression in medulloblastoma and gliomas, plasmid profiling,
unique mutations in beta-thalassemia and presently working on miRNAs targets of herbal extract with potentials of anti-cancer drug.