The power of analytics is enabling the pharmaceutical industry to improve insights on drug safety to strengthen patient care at large. But limited data exists on the effectiveness of these various methodologies. In addition, there is an opportunity to identify new data sources and / or novel methodologies which could drive further understanding of product profiles and support product development. This initiative aims to develop best practices and guidance around the application of interrogative methods towards various safety data sources.
- Earlier identification of potential safety issues to help minimize harm to patients
- Improved quality data analytics and verified methodologies could enable a more informed product development outcome
- Accelerated method development and sharing of best practices through collaboration and piloting
Please check back for more information on the initiative assets in Q4-2019.
Value of Safety Information Data Sources
The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for a single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.
Interpretation of Guidances & Regulations
The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.
Intelligent Automation Opportunities in Pharmacovigilance
The Intelligent Automation initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes.