CIRS RD Briefing 38 – Risk management
Highlights of the CMR International institute Workshop on Risk Management: The role of regulatory strategies in the development of new medicines, Washington DC, 12-13 December 2002 Following a number [...]
CIRS RD Briefing 37 – Adoption of ICH E5 in Asia Pacific
In 2001, CMR International conducted a study among pharmaceutical companies to evaluate their experience with regulatory authorities in Asia Pacific regarding the acceptance of foreign clinical data and adoption [...]
CIRS RD Briefing 36 – Impact of ICH E5 guideline
The ICH E5 Guideline was introduced in February 1998 and subsequently implemented by the regulatory authorities of the USA, EU and Japan. The purpose of this guideline is to [...]
CIRS RD Briefing 31 – Regulatory review times
CMR International R&D Briefing 31 - Profile of performance: Review times - is there still room for improvement? Key messages: Performance improvement initiatives established by regulatory authorities in the [...]