Top 3 Pharmacovigilance Challenges and Respective Solutions
Pharmacovigilance (PV) is gaining importance worldwide amid recurring issues of adverse drug reactions
. With a global increase in major drug withdrawals, the challenge of maximizing drug safety and maintaining public confidence has become increasingly complex. Following are the top 3 challenges faced by the PV industry in today's market and their respective solutions:
Complying with local and global pharmacovigilance requirements: Recently, PV companies are facing issues while attempting to meet regulatory protocols and global standards. Due to varying regulations among different countries, being compliant on a global scale has become increasingly difficult in all PV activities.. The challenge of understanding the various regulatory policies of each country and efficiently adapting your processes to them is something many organizations are struggling with.
Solution: To meet all the global and local regulatory compliance, try to understand the relevant country's legislation and the new guidelines on monitoring and compliance. One should participate in various regulatory educational programs, webinars or seminars, and respond to the enquiries of regulatory obligations through scrutiny of standard operating procedures and PV inspections.
Evaluate Available Safety Data and Prepare an Accurate Safety Database: Utilizing a global validatedsafety database is another key challenge that pharmaceutical companies are forced to address. Most of organizations find it tough to validate and implement an effective safety database given the time and costs associated with such an undertaking.
Solution: Ensure that there is a central contact point to address all safety database related queries and complaints. Any Adverse Reaction reports received can then be entered into the safety database, analyzed in terms of seriousness, report-ability and causality.
PV Structure/Framework: To meet the necessary regulatory obligations, one needs the right IT infrastructure in place and adequate resources to manage and maintain the application and infrastructure. This requires proper documented procedures and skilled staff in order to stay compliant with the most recent regulations.
Solution: You would need a very good infrastructure support to carry out your PV project successfully. This you can build in-house or go for a contractual arrangement with other organizations Involved in the Fulfillment of Pharmacovigilance Obligations. The idea is to gain access of an advanced PV/IT infrastructure that allows you to serve your end-customers in a cost-effective yet efficient manner.
Top 3 Pharmacovigilance Challenges and Respective Solutions