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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
CIRS RD Briefing 37 – Adoption of ICH E5 in Asia Pacific
In 2001, CMR International conducted a study among pharmaceutical companies to evaluate their experience with regulatory authorities in Asia Pacific regarding the acceptance of foreign clinical data and adoption [...]
CIRS RD Briefing 36 – Impact of ICH E5 guideline
The ICH E5 Guideline was introduced in February 1998 and subsequently implemented by the regulatory authorities of the USA, EU and Japan. The purpose of this guideline is to [...]
CIRS RD Briefing 31 – Regulatory review times
CMR International R&D Briefing 31 - Profile of performance: Review times - is there still room for improvement? Key messages: Performance improvement initiatives established by regulatory authorities in the [...]