While efforts around pharmacovigilance have made substantial progress in the past several decades, the biopharmaceutical industry shares a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts. As science and technology advances, and patients step into the forefront of their own care, the nature of these challenges have provided new opportunities to reassess areas for improvement.
Our Pharmacovigilance portfolio aims to address some of these challenges using TransCelerate’s collaborative model implemented against our Clinical Portfolio. Please take the time to explore our Initiatives below.
Interpretation of Pharmacovigilance Regulations
The Interpretation of Pharmacovigilance Regulations Initiatives will share expertise to more efficiently and effectively meet the intent of pharmacovigilance requirements that seem ambiguous.
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.