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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Regulating personalised medicines 14-15th April 2003, Surrey, UK The unravelling of the human genome and advances in genetic research are now opening up new horizons in the understanding of [...]
Risk management workshop: Identifying and developing effective stakeholder communication during drug development 12-13th December 2002, Washington DC, USA "Risk is complex and in managing it we must be aware [...]
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 [...]