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’ [...]
Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies
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 [...]
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, [...]
CIRS RD Briefing 46: Building quality into regulatory activities
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 [...]
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 [...]
CIRS RD Briefing 50 – Cross-regional comparison of regulatory environment in emerging markets
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 [...]
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 [...]
CIRS RD Briefing 49 – Accessing the regulatory environment – Latin America
The Regulatory Agencies in Latin America share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines become available to patients [...]