Regulatory Programme

Roadmap

Regulatory Programme: Exploring new paradigms in development and review

CIRS interacts with more than 24 regulatory agencies throughout the emerging and developed markets to understand the benefits and barriers associated with their systems. We are advised by member companies and agencies as to the challenges and opportunities that can be addressed or enhanced by the findings of Regulatory Science. This input guides CIRS in its development of tools and promulgation of recommendations to improve the discovery, development and review processes.

In this regard, key CIRS activities include:

Benefit-Risk assessment: the development of a globally applicable benefit-risk framework to communicate findings of assessments to diverse stakeholder groups
Quality reviews: the creation of Quality Scorecards with which industry can rate the quality of regulatory reviews and regulators can assess the quality of dossier submissions
Benchmarking: understanding the development and assessment processes for dossiers provides the basis for monitoring development, submission and review times
Workshops: focus on specific topics in Regulatory Science, informed by the real-world needs of member companies and participating regulatory agencies