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.
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
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 …
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 …
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 …
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 …
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 …
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 …
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 …
CIRS RD Briefing 38 – Risk management
Highlights of the CMR International institute Workshop on Risk Management: The role of regulatory strategies in the development of new medicines, Washington DC, 12-13 December 2002 Following a number of …