2006 Workshop report – Quality decision making
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’ [...]
2006 Workshop report – Asia’s role in global drug development
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 [...]
2006 Workshop report – New technologies and biomarkers
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, [...]
2006 Workshop report – Emerging markets regulatory issues and impact on access
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 [...]
2005 Workshop report – Structured approach to benefit risk decision making
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 [...]
2005 Workshop report – A new paradigm for clinical research
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 [...]
2005 Workshop report – Post approval commitments and conditional authorisations
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 [...]
2004 Workshop report – Building quality into regulatory dossiers and review
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 [...]
2004 Workshop report – Beyond benchmarking: Metrics to measure performance
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 [...]
2004 Workshop report – Global drug development
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 [...]