jsharpe

About Jenny Sharpe

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So far Jenny Sharpe has created 168 blog entries.

CIRS RD Briefing 95 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2019-2023

This R&D Briefing presents data from HTADock, an ongoing metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies, each with [...]

Rare Disease Product Approvals: The Changing Regulatory And HTA Landscape Between 2018-2022

Background Globally, 7,000 rare diseases affecting 300 million people pose development challenges with small patient populations. Developing medicines for rare diseases requires innovation. Despite regulatory incentives, challenges for HTA [...]

Navigating HTA Requirements During Development Through Early HTA Scientific Advice

Background Pharmaceutical companies have been actively taking early scientific advice from health technology assessment (HTA) agencies during development, with the aim to understand the HTA evidentiary requirements. The evolving [...]

2024-08-01T16:00:58+00:00August 1st, 2024|Tags: , |

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 [...]

2024-10-30T10:36:07+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: |
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