Proactive PV approaches address operational excellence to facilitate on going quality and compliance coupled with process effectiveness
26 August 2014, Boston, MA – 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 10th September, will outline the strategic challenges facing marketing authorization 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. In order 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 organizational readiness for the externalizations of PV activities, as well as what an optimized 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 two 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 pre-marketing safety.
To meet with Sciformix at WDSC and/or receive a copy of the presentation, contact us at Bizteam@sciformix.com.
To learn more about Sciformix visit www.sciformix.com, email us at firstname.lastname@example.org, or call us at +1.877.576.5005.
For further press information please contact: David Bertram, The Scott Partnership: + 44 1477 539539 mail to email@example.com or Susan Najjar, Director of Marketing, Sciformix Corporation: + 1 617-264-0339 mail to firstname.lastname@example.org.
Sciformix Corporation is a leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies – in the areas of Safety and Risk Management, Clinical Research & Post-Approval Support and Regulatory Affairs. Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise to deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.
We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from pre-clinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.
Sciformix is dedicated to providing our clients outstanding services and solutions, fuelled by an unrivalled commitment to quality. We share the same level of involvement, dedication and passion as our clients and become an integral part of their team. Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results. Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.