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.
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 …
2005 Workshop report – Structured approach to benefit risk decision making
Benefit-risk assessment model for medicines – Developing a structured approach to decision making 13-14th June 2005, The Georgetown Inn, Washington DC, USA As public accountability grows for decisions taken in …
2005 Workshop report – A new paradigm for clinical research
A new paradigm for clinical research 3rd-4th October 2005, Mandarin Oriental Hotel, Washington DC, USA Current paradox The pharmaceutical industry’s investment in R&D is rising inexorably but success rates are …
CIRS RD Briefing 49 – Accessing the regulatory environment – Latin America
The Regulatory Agencies in Latin America share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines become available to patients in …
CIRS RD Briefing 48 – Assessing the regulatory environment – Middle East and Africa
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This is …
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 …