Journal of Pharmacovigilance

Safety database updates: Past and future trends driving the decision to upgrade

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Amanda Bowles

Deloitte�??s Strategy and Operations Consulting, USA

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

We are often asked the question �??When should I upgrade my safety database?�?� There are obvious answers when it comes to maintaining regulatory compliance and ensuring patient safety. However, companies are often driven to upgrade their systems based on other factors, such as resource efficiency, business harmonization, analytic capabilities and aging technologies. Making the decision to upgrade requires weighing these factors against the cost and effort to implement, and is often a difficult challenge to evaluate. A review of historical information across the industry reveals common upgrade drivers. The upgrade drivers go beyond regulatory compliance and patient safety and uncover the complexities in how companies evaluate business operations and capabilities against cost and effort. Evaluating cost and effort drives the implementation strategy, and is often informed by a company�??s past upgrade experience with safety database implementations. Trends in the healthcare and pharmacovigilance industry will cause a shift in the significance of common upgrade drivers. As costs grow disproportionately to the value obtained from each upgrade, life science companies are re-evaluating their approach safety database upgrades. This session will explore this balance between upgrade drivers and the level of cost and effort to implement, as well as how this balance will change in the future.

Biography :

Email: abowles@deloitte.com