Regulatory

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 [...]

2024-12-18T16:21:49+00:00December 1st, 2002|Tags: , |

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 [...]

2021-02-12T12:24:50+00:00October 1st, 2002|Tags: |

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 [...]

2021-02-12T12:30:29+00:00February 1st, 2001|Tags: |
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