Emerging markets: Models of best practice for the regulatory review of new medicines 5-6th December 2007, Geneva, Switzerland The CMR International Institute for Regulatory Science returned to Geneva for [...]
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’ [...]
Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]
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, [...]
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 [...]
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines [...]