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.
CIRS RD Briefing 47 – Accessing the regulatory environment – SE Asia and Western Pacific
The regulatory agencies in South East Asia and the Western Pacific share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines …
2005 Workshop report – Post approval commitments and conditional authorisations
Post-approval commitments and conditional authorisations 12-13th May 2005, Woodlands Park Hotel, Surrey, UK Background When a marketing approval is issued for a new medicine there are always certain statutory conditions …
2004 Workshop report – Building quality into regulatory dossiers and review
Building quality into regulatory dossiers and the review process: Knowing and meeting customer expectations 2nd-3rd December 2004, Woodlands Park Hotel, Surrey, UK Overview This was the fourth Workshop organised in …
2004 Workshop report – Beyond benchmarking: Metrics to measure performance
Beyond benchmarking: What are the key metrics that agencies and companies should use to measure performance? 4-5th October 2004, Lansdowne Resort, Virginia, USA Why participate in benchmarking exercises? This question …
CIRS RD Briefing 44: Global drug development and regulatory review
Although it is the goal of most major pharmaceutical companies to achieve global development for new medicines with simultaneous submission of the regulatory dossier in the three main ICH regions, …
CIRS RD Briefing 43: Current strategies in global drug development
A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies. Although the pharmaceutical industry is moving towards integrated global …
2004 Workshop report – Global drug development
Global drug development: Issues for the pharmaceutical industry and regulatory authorities 26-27th May 2004, Tokyo, Japan Overview Although most of the major pharmaceutical companies are moving towards simultaneous development and …
CIRS RD Briefing 45: Regulatory timelines in Saudi Arabia
This unique study is the first in-depth analysis of the trends and changes in the regulatory approval times for medicines in the Kingdom of Saudi Arabia. Not only have the …
CIRS RD Briefing 42: Changing regulatory environment
A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies and regulatory agencies. There was consensus that the regulatory …
CIRS RD Briefing 41 – Workshop on Regulatory Performance
Highlights from the workshop entitled ‘Regulatory Performance: Critical Success Factors in Today’s Environment’, held by the CMR International Institute for Regulatory Science in Washington D.C., 15-16 September 2003 In recent …
2004 Workshop report – Development of a model for benefit-risk assessment
Development of a model for benefit-risk assessment of medicines based on multi-criteria decision analysis 29-30th March 2004, London School of Economics (LSE), UK The primary objective of the meeting was …
CIRS RD Briefing 40 – Pharmacogenetics and pharmacogenomics in drug development
Summarised results of a survey carried out among pharmaceutical companies and regulatory agencies, by the CMR International Institute for Regulatory Science Pharmacogenetic (PGt) and pharmacogenomic (PGx) technologies are being applied …
CIRS RD Briefing 39 – Regulating personalised medicine
Highlights of the workshop “Regulating personalised medicine” organised by the CMR International Institute for Regulatory Science, Nutfield Priory, Surrey, UK, 14-15 April 2003 The unravelling of the human genome and …
2003 Workshop report – Regulatory performance: Critical success factors
Regulatory performance: Critical success factors in today’s environment 15-16th September 2003, Washington DC, USA Participants at the CMR International Institute Workshop on Regulatory Performance found them in the unique position …
CIRS RD Briefing 38 – Risk management
Highlights of the CMR International institute Workshop on ‘Risk Management: Identifying and Developing Effective Stakeholder Communication During Drug Development’, held on 12-13 December 2002. Following a number of high profile …