Risk Management for the 21st Century: Current Status and Future Needs

Area of Science:

• Pharmacovigilance and Drug Safety
• Benefit-Risk Management
• Regulatory Science

Background:

• International Conference on Harmonisation (ICH) E2E and Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidelines enhanced pharmacovigilance.
• Significant scientific and practical advancements have occurred in risk minimization measures (RMMs) since these guidelines were released.
• Focus has shifted to the design, implementation, dissemination, and real-world effectiveness evaluation of RMMs.

Purpose of the Study:

• To describe advancements in the design, implementation, dissemination, and evaluation of RMMs.
• To highlight current challenges and propose potential solutions in RMM practices.
• To advocate for global harmonization in specific aspects of RMMs.

Main Methods:

• Review of recent advances in the science and practice of RMMs.
• Analysis of evidence-based approaches informing RMM development.
• Inclusion of global examples illustrating effective RMM strategies.
• Consideration of local healthcare system policies and national legislations.

Main Results:

• The field of RMMs has progressed significantly in design, implementation, dissemination, and evaluation.
• Evidence-based approaches are increasingly informing the development of RMMs.
• Global examples demonstrate successful implementation of advanced RMM strategies.

Conclusions:

• There is a need for a global effort to harmonize specific areas of RMMs.
• Harmonization should focus on standardizing terms, definitions, and methodologies.
• Best practices for RMM design, implementation, and dissemination require outlining.