Policy, Regulatory, and Legal Pharmacoepidemiology (PRLP) SIG

Mission Statement

To advance the credible evaluation of how laws, regulations, and health policies shape the utilization, access, and safety of medical intervention. The SIG provides a forum for pharmacoepidemiologists, health policy researchers, legal epidemiologists, and related policy stakeholders to develop and apply causal inference methods, to integrate policy surveillance and legal mapping into study design and exposure definition, and to strengthen the translation of real-world evidence into the policy and regulatory settings where it informs decisions. The SIG aims are two-fold: inform relevant policy, law and regulation and work on methods to evaluate them using real-world data. 

Objectives

• Convene methodological discussion on research designs for policy evaluation as applied to the use, benefits, and risks of medical products and interventions in human populations.
• Promote the use of policy surveillance and legal mapping as structured variables in pharmacoepidemiologic research.
• Foster dialogue on the evolving real-world evidence regulatory landscape and its intersection with legislation affecting the access, utilization, and safety of medical interventions.
• Provide a venue at ISPE scientific meetings for policy-focused pharmacoepidemiology and for engaging early-career researchers in legal epidemiology and health policy intiatives.
• Build connections with adjacent disciplines and external initiatives, including health law, health economics, and regulatory science.

SIG leader(s)