Sciformix Corporation, a leading scientific process organization (SPO), will showcase proactive pharmacovigilance (PV) approaches and best practices at this year’s World Drug Safety Congress (WDSC) Europe, which will take place in London, 10–11 September. These approaches will allow the pharma industry to address increasingly stringent PV requirements along with global expansion and increasing workloads.
The presentation entitled ‘Next Generation PV — Achieving Operational Excellence to Ensure Compliance and Quality’, to be delivered by Boris Jankowski, director of solutions architecture at Sciformix in the Woburn Suite at 15:20 BST on Wednesday 10 September, will outline the strategic challenges facing marketing authorisation holders and how they can implement various models to facilitate compliance with the evolving global regulatory requirements. The presentation will go on to provide best practices in working with partners to deliver end-to-end pharmacovigilance services.
Mr Jankowski, commented: “The on-going regulatory developments and the industry’s expansion into emerging markets have substantially raised the bar for conducting pharmacovigilance on a global scale. To meet these challenges, new proactive approaches in delivering pharmacovigilance services are required. While the presentation at WDSC will provide delegates with best practices in achieving operational excellence, it will also convey the opportunities and challenges related to the evolving global corporate and regulatory changes, and how these influence the new PV operating models.”
He continued: “The current regulatory environment dictates that it is vital for companies to understand how to assure organisational readiness for the externalisations of PV activities, as well as what an optimised partnership model should look like so that companies can employ operational excellence and achieve on-going quality and compliance. The WDSC is a fantastic opportunity for the industry as a whole to come together and foster a greater understanding of the new drug safety/PV initiatives, the global regulatory environment and the associated complexities affecting the management of drug safety. Together with this, we are provided with a platform for discussion and planning on what the future of drug safety will hold.”
The 7th WDSC, taking place at The Hotel Russell, London, will embrace key aspects of pharmacovigilance, signal detection, clinical safety, regulations and benefit/risk management. Spanning 2 days, the congress will focus on the international drug safety landscape, the global regulatory environment, increasing complexities affecting the management of drug safety, data management and electronic submissions, financial and logistical constraints, clinical safety and the limitations to premarketing safety.