Global PV majors adopt risk management strategies as regulators impose high penalties for non compliance
|Nandita Vijay, Bengaluru
Saturday, March 31, 2012, 08:00 Hrs [IST]
Global pharmacovigilance companies are now pursuing a path of risk management because of the stringent regulatory inspections and penalties imposed for non-compliance. This has led to high staff turnover at not just the regulatory offices but departments of pharmacovigilance at companies and clinical research organizations (CROs) abroad.
In this scenario India has a chance to increase its presence in supporting pharmacovigilance assignments for the developed markets. Some of the key assignments cover simple data entry for adverse events, individual case medical evaluation, aggregate report preparation and safety issue analysis, stated Dr Stewart Geary, vice president and deputy director of Corporate Regulatory Compliance, Safety & QA, Eisai Co. Ltd. Japan.
Pharmacovigilance is a critical component in drug development. There are numerous and complex changes affecting a wide range of pharmacovigilance activities. Regulations which include US FDA guidance on Risk Minimization Action Plan, new emphasis on inspections by the MHRA and other European countries have made pharmacovigilance assignments challenging for regulatory inspectors abroad. Europe is in the midst of a pharmacovigilance regulatory change. The legislation adopted in December 2010 will be implemented July 2012. These include creation of Pharmacovigilance Master File, Reporting in EU drug vigilance database format and formation of New Pharmacovigilance Risk Assessment Committee (PRAC).
The content and focus of the inspection is both vast and complicated which is leading to high staff turnover and burnout not just at the regulatory offices by also at the departments of pharmacovigilance of companies and CROs in the developed markets. It is now stressful for the regulatory staff and company managements, he added.
Dr Geary who was in India in connection with the Drug Information Association, India (DIA) event on pharmacovigilance pointed out that pharmaceutical industry economics have been transformed. There is decline in R&D productivity and efficiency. Companies are putting up with failures of blockbuster drug development model. There is wider and more aggressive adoption of generics since Hatch-Waxman Act in US.
New regulations have created wider scope for inspection and findings. There is an increase in penalties for noncompliance and jail terms for company executives imposed for failure to comply with regulations “We see that global pharma majors are pursuing a path of risk management and risk minimization leading to increase in safety communications and supply restrictions during marketing,” he said.
There is also greater focus on cost controls and this is where the developed world is looking at the emerging economies in South East Asia, South America and Asian region to drive economies-of scale. But there are challenges to work over long distances. Developed markets would have to put up with the learning curves of emerging markets as different companies have different pharmacovigilance practices.
While some skills are transferrable between clients, many procedures and standard operating procedures (SOPs) are unique to one client. Another issue is that with high staff turnover, training needs to constantly conducted, informed Dr Geary.
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