Publications
CIRS publishes insights from its research and meetings in several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA benchmarking briefings
- Journal articles – peer reviewed academic research papers
- Reports – from CIRS workshops and externally commissioned research projects, as well as CIRS Annual Reports
- Books – research theses from CIRS-supported PhD students
- Posters – presented at external conferences
Keep up-to-date with CIRS publications and activities by signing up to our mailing list or following CIRS on LinkedIn.
Bujar et al 2019 – Quality decision making in Health Technology Assessment
Background: To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process …
Bujar et al 2019 – Reliability and relevance of a decision-making instrument
Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality of …
2018 Forum report – Managing uncertainties for products using early access pathways
In November 2018, a collaborative forum presented by CIRS and the Utrecht University WHO Collaborating Centre for Pharmaceutical Policy and Regulation brought together regulatory, HTA, industry and academic perspectives with …
2017 Workshop report – Flexible regulatory/access pathways
The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) and …
CIRS RD Briefing 69: Review of HTA outcomes and timelines 2014-2017
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an …
CIRS RD Briefing 68: Regulatory and HTA decision making and access to medicines – the consequences of sequence
Historically, every jurisdiction with some form of regulatory agency capacity has undertaken the review of medicines as a first step in the market access process. This step is intended to …
Wang et al 2018 – Building Synergy between Regulatory and HTA Agencies
Objectives: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of …
2018 Workshop report – Practical implementation of reliance models
This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be utilised …
CIRS RD Briefing 67 – New approvals in six regulatory authorities 2008-2017
Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a decrease in the time to marketing authorisation as well as an …
CIRS RD Briefing 66 – Benefit-Risk Assessment Tool (BRAT)
A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team …
CIRS RD Briefing 65 – New approvals in six regulatory authorities 2007-2016
Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceutical companies have resulted in more new active substances (NASs) being internationalised, referring …
Quality decision-making practices
This book compiles the presentations and syndicate discussions from a CIRS workshop that brought together representatives from international pharmaceutical companiesand regulatory authorities from Europe, US, Canada and Australia and HTA …
CIRS RD Briefing 64: Review of HTA outcomes and timelines 2014-2015
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure patient access to medicines of therapeutic value. As part of an ongoing study to monitor …
CIRS RD Briefing 63: HTA process maps
This R&D Briefing summarises the background and methodology of process mapping with examples to demonstrate the steps involved in regulatory, HTA and coverage processes for new medicines. Process maps have …
2017 Workshop report – Facilitating review through risk-based evaluations
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused specifically …