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.
2009 Workshop Report – Acceptability of data generated from foreign clinical trials and ethnic factors in drug development
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.
Liberti et al 2010 – Progress on the development of a benefit-risk framework for evaluating medicines
CIRS authors write about benefit-risk in the March 2010 issue of Regulatory Focus by the Regulatory Affairs Professionals Society (RAPS). Article reproduced with the permission of RAPS. Download
2009 Workshop report – Review and reimbursement: A special case for better co-operation
Review and reimbursement: A special case for better co-operation 29-30th September 2009, Surrey, UK The current dynamics of bringing new medicines to market are influenced by potential conflicts between the …
2009 Workshop report – Strategies for communicating benefits and risks to decision makers
Strategies for communicating benefits and risks to decision makers: Explaining methods, findings and conclusions through a common language approach 17-19th June 2009, Washington DC, USA Determining the benefit-risk (BR) balance …
2009 Workshop report – Expediting patients’ access to medicines: Solutions to simultaneous submissions and approvals
Expediting patients’ access to medicines: Solutions to simultaneous submissions and approvals 20-31 March 2009, Surrey, UK Major companies engaging in global development programmes are currently trying to reduce the development …
2008 Workshop report – Predictable outcomes: Why do potential winners fail?
Predictable outcomes: Why do potential winners fail? 30th September – 1st October 2008, Washington DC, USA A little more than 10% of new compounds that are at the first-human-dose evaluation …
2008 Workshop report – Clinical development in Asia, Africa and Latin America
Clinical development in Asia, Africa and Latin America: Streamlining the procedure for obtaining global clinical trial approvals 1st-2nd December 2008, Intercontinental Hotel, Singapore Is the concept of the simultaneous global …
2008 Workshop report – Measuring benefit and balancing risk
Measuring benefit and balancing risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment 19-20th June 2008, Sofitel Lafayette Square, Washington DC, USA Measuring the benefits and …
2008 Workshop report – Knowledge sharing and cooperation
Knowledge sharing and co-operation – Are these the key to a more certain future for pharmaceutical innovation? 29-30th April 2008, Surrey, UK Altruism or enlightened self-interest – what are the …
2008 Workshop report – Regulation and reimbursement
Regulation and reimbursement – Two sides of the same coin? 16-17th January 2008, Surrey, UK Background The topic for this Workshop, held in Surrey, UK, January 2008, was a departure …
2007 Workshop report – Emerging markets: Models of best practice for regulatory review
Emerging markets: Models of best practice for the regulatory review of new medicines 5-6th December 2007, Geneva, Switzerland The CMR International Institute for Regulatory Science returned to Geneva for its …
2007 Workshop report – New approaches to product approval
New approaches to product approval – Balancing early release with improved safety monitoring 14-15th June 2007, Sofitel Hotel, Washington DC, USA Different approaches have been adopted worldwide to make new …
2007 Workshop report – Rethinking early clinical testing
Rethinking early clinical testing: The translation from laboratory to clinic 16-17th April 2007, Surrey, UK In March 2006, just over a year before this CMR International Institute Workshop took place, …
2006 Workshop report – Quality decision making
Quality decision making: Procedures and practices in drug development and the regulatory review 7-8th December 2006, Surrey, UK Benefit and risk for patients, the success or failure of companies’ multi‑million‑dollar …
Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies
Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process across …