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 [...]