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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]