New approaches to product approval - Balancing early release with improved safety monitoring 14-15th June 2007, Sofitel Hotel, Washington DC, USA Different approaches have been adopted worldwide to make [...]
Rethinking early clinical testing: The translation from laboratory to clinic 16-17th April 2007, Surrey, UK In March 2006, just over a year before this CMR International Institute Workshop took [...]
Quality decision making: Procedures and practices in drug development and the regulatory review 7-8th December 2006, Surrey, UK Benefit and risk for patients, the success or failure of companies’ [...]
Global drug development: Asia's role and contribution 11-12th October 2006, Tokyo, Japan The pharmaceutical market in the Asia‑Pacific region (excluding Japan) currently accounts for less than 20% of the [...]
New technologies and biomarkers: The way ahead 11-12th May 2006, Washington DC, USA Overview Once again, the CMR International Institute for Regulatory Science assembled an impressive team of regulatory, [...]
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 [...]
