jsharpe

About Jenny Sharpe

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So far Jenny Sharpe has created 152 blog entries.

CIRS RD Briefing 93 – New drug approvals by six major authorities 2014-2023

This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]

Assessing the use of risk-based approaches in four major agencies

Introduction Over the last years, several regulatory agencies have developed risk-based approaches for the regulatory assessment of marketing authorisations of New Active Substances (NASs) as strategies to efficiently use [...]

2024-07-09T15:21:30+00:00July 9th, 2024|Tags: , , |

CIRS 2023 Annual Report

We're delighted to present our latest Annual Report, which provides a summary of the projects, publications, multi-stakeholder workshops and Technical Fora from Regulatory and HTA workstreams undertaken in 2023. [...]

2024-07-03T16:31:26+00:00July 3rd, 2024|Tags: |

CIRS RD Briefing 94 – Value of Reference Agency Reports in Enabling Reliance

Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was [...]

2024-06-20T09:33:23+00:00June 20th, 2024|Tags: , , |

CIRS RD Briefing 92 – Appraising the usability of public assessment reports for reliance

Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]

2024-05-31T08:07:57+00:00May 29th, 2024|Tags: , , |

New CIRS Research Agenda

We're pleased to announce that CIRS has published a new Research Agenda, which can be downloaded here. This brochure outlines our research priorities for 2024-2026 as well as plans for [...]

2024-04-24T13:34:55+00:00April 24th, 2024|
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