Frequently asked questions (FAQs)
What is CIRS?
The Centre for Innovation in Regulatory Science (CIRS) is a neutral research organisation that provides a forum for policy leaders from government regulators, health technology assessment (HTA) agencies, the pharmaceutical industry, and other stakeholders in healthcare, such as patient organisations and academia. We focus on improvements in policies and processes for regulation and HTA. CIRS works collaboratively with stakeholders worldwide and its activities are underpinned by three key pillars: metrics, quality and alignment.
How is CIRS funded?
CIRS operates as a not-for-profit organisation, deriving funding from industry membership dues, special projects, and grants from non-profits and governments to cover operating and research costs.
What is CIRS’ relationship with Clarivate?
CIRS is a UK-based subsidiary of Clarivate plc and conducts research independently. We have our own dedicated management and advisory boards that provide direction for our Research Agenda. There is a firewall in place so that no confidential information, such as data, insights or contacts, is shared with Clarivate.
How does CIRS handle agency/company data?
CIRS understands the sensitivity of agency/company data and has over 30 years of experience handling such information. All data from organisations that we work with are kept strictly confidential. No identifying information will be publicly reported or shared with third parties without explicit written consent from the providing organisation.
What makes CIRS unique?
What sets us apart is our ability to facilitate safe harbour discussions between multiple stakeholders involved in drug development and patient access to medicines. CIRS meetings are usually small, focused and build on discussions from previous meetings to enable continuous evolution of a topic. They also include breakout sessions, which are key to producing recommendations to help effect change.
We are evidence-driven and transparent in our work. The data we collect are used to support our workshops and we endeavour to make these publicly available through peer-reviewed journals or our R&D Briefings.
Our small but dedicated team strive to ensure that the needs and priorities of our stakeholders are at the heart of CIRS activities. Our door is always open to new ideas and suggestions that fit with our mission.
What impact has CIRS had?
CIRS has a 30+ year history of helping to improve the regulatory and HTA landscape through its work in the areas of metrics, quality and alignment. For example, CIRS has laid the foundations for the development of practices for building quality into review and decision-making processes. This has helped to define Good Review Practices and increase the quality of processes by using structured frameworks and ensuring documentation. This is both for specific processes such as benefit-risk and for ensuring quality of decision making in general.
You can find out more about CIRS’ impact in our Annual Reports.
How is the CIRS research agenda governed?
CIRS has its own dedicated advisory committees made up of external international experts from academia, industry, regulatory agencies, HTA bodies and payers, which ensure neutrality and that the CIRS Research Agenda meets all stakeholder needs. We set our three-year Research Agenda with input from the Scientific Advisory Council (SAC) and HTA Steering Committee, as well as feedback from companies and agencies. Please see the Governance page for current lists of committee members.
How is CIRS different to other membership organisations?
CIRS is unique in its ability to bring global industry, regulators, HTA bodies, payers and academics together in a neutral atmosphere to identify and address key issues in the development, licensing and reimbursement of new medicines. We have been doing this for over 30 years through focused meetings and research projects, which are often conducted in collaboration with agencies and/or industry.
How are CIRS meetings different from other professional conferences?
CIRS meetings are usually small and focused to facilitate discussion among multiple stakeholders. Our workshops also include breakout sessions, which are key to producing recommendations to move important topics forward.