As we all are aware that pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems; however the concerns of pharmacovigilance (PV) are increasing nowadays for herbals, blood products, biological, medical devices, vaccines and traditional medicines too. These concerns include lack of efficacy reports, substandard medicines, medication errors, case reports of acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of medicines, use of medicines for indications that are not approved and for which there is inadequate scientific basis, adverse interactions of medicines with chemicals, other medicines, and food.

As per current scenario and increased number of clinical trials, the PV market is expected to reach USD 10.27 billion by 2025 globally; however that would be impacted by certain factors which are responsible for a PV system, its strength and reliability which include patient count, database systems, collection of data, and analysis of data, reports creation and submission. For a quality data, individual case safety report should be properly created which depend upon “4 major elements” including an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. Careful coding of adverse events requires a thorough understanding of verbatim terms using standardized terminology from a medical coding dictionary.

Determination of seriousness of adverse events considering their interpretation is also very critical where comes the role of CTCAE (Common Terminology Criteria for Adverse Events). One of the hugely important, and challenging, problems in PV is the determination of causality because of the lack of clear-cut or reliable data. Therefore to support the post clinical data with secured databases and robust reports, role of the team which plays an important role becomes extremely critical. Doing these activities in-house or outsourcing these to qualified vendors is something every sponsor company should be critically thinking; not because submission of these reports is a regulatory requirement, but also required to sustain a particular medication for longer period in the market. Hence, it becomes a core necessity for a sponsor to practice the PV activities with proper guidance and guidelines of regulatory authorities.

Understanding this fact, we, the team of “Virtue Medical Services” supports you with best quality data reports for successful submissions.

To know more on PV; be a part of our next event, i.e 16^th Pharmacovigilance 2018 which is going to be held in October 2018, Cambridge, USA. Find more details on http://www.virtueinsight.com/upcoming-conferences/