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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Global drug development: Issues for the pharmaceutical industry and regulatory authorities 26-27th May 2004, Tokyo, Japan Overview Although most of the major pharmaceutical companies are moving towards simultaneous development [...]
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 [...]
