Regulatory

CIRS RD Briefing 42: Changing regulatory environment

A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies and regulatory agencies. There was consensus that the [...]

2021-01-29T11:49:19+00:00August 1st, 2004|Tags: |

CIRS RD Briefing 41 – Workshop on Regulatory Performance

Highlights from the workshop entitled 'Regulatory Performance: Critical Success Factors in Today’s Environment', held by the CMR International Institute for Regulatory Science in Washington D.C., 15-16 September 2003 In [...]

2021-02-08T14:26:15+00:00April 1st, 2004|Tags: |

CIRS RD Briefing 40 – Pharmacogenetics and pharmacogenomics in drug development

Summarised results of a survey carried out among pharmaceutical companies and regulatory agencies, by the CMR International Institute for Regulatory Science Pharmacogenetic (PGt) and pharmacogenomic (PGx) technologies are being [...]

2021-02-08T16:35:20+00:00December 2nd, 2003|Tags: |

CIRS RD Briefing 39 – Regulating personalised medicine

Highlights of the workshop "Regulating personalised medicine" organised by the CMR International Institute for Regulatory Science, Nutfield Priory, Surrey, UK, 14-15 April 2003 The unravelling of the human genome [...]

2021-02-08T16:35:36+00:00December 1st, 2003|Tags: |

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 [...]

2021-02-12T12:05:12+00:00June 1st, 2003|Tags: |

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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