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.
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 …
2006 Workshop report – Asia’s role in global drug development
Global drug development: Asia’s role and contribution 11-12th October 2006, Tokyo, Japan The pharmaceutical market in the Asia‑Pacific region (excluding Japan) currently accounts for less than 20% of the global …
2006 Workshop report – New technologies and biomarkers
New technologies and biomarkers: The way ahead 11-12th May 2006, Washington DC, USA Overview Once again, the CMR International Institute for Regulatory Science assembled an impressive team of regulatory, industry …
CIRS RD Briefing 46: Building quality into regulatory activities
The Institute for Regulatory Science is currently involved in several activities related to quality as it applies to regulatory submissions and procedures, rather than the more conventional association with the …
2006 Workshop report – Emerging markets regulatory issues and impact on access
Emerging markets: Regulatory issues and the impact on patients’ access to medicines 2nd-3rd March 2006, Geneva, Switzerland Introduction Convened in Geneva, close to the headquarters of the World Health Organization …
CIRS RD Briefing 50 – Cross-regional comparison of regulatory environment in emerging markets
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines and …