Historically, pharmacovigilance has been viewed as a time-consuming challenge, suffering from confusion and misalignment on industry approaches regarding regulations, as well as divergence in regulations across global health authorities.
The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of pharmacovigilance requirements that seem ambiguous. The initial focus will be recent measures such as the IND safety reporting requirements, but over time the Initiative hopes to work proactively with health authorities toward modernized and internationally harmonized pharmacovigilance.
This initiative will benefit patients, sponsors, and regulators through:
- Improved patient safety from a more reliable interpretation of regulations
- Reduced sponsor compliance risks by better understanding of regulations
- Increased efficiencies for regulators because of potential reductions in compliance issues
This initiative will deliver the following assets and activities:
- Interpretation and implementation best practices catalog for the IND Safety Reporting Regulations
- Framework and process for interpreting and implementing regulations that promote collaboration with and across regulators
- Outreach to regulators regarding initiative intent and interpretation of selected pharmacovigilance regulation
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.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
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.