jsharpe

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So far Jenny Sharpe has created 139 blog entries.

CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies

This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]

2024-02-21T16:28:45+00:00February 21st, 2024|Tags: , , , , |

HTA Timelines and Outcomes for MHRA-Approved NASs via Reliance/Work-sharing Routes

During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes'. Background: [...]

2024-02-12T12:09:04+00:00December 12th, 2023|Tags: , , |

CIRS RD Briefing 90 – Challenges and opportunities for orphan medicines availability in Mexico

The document ‘Estrategia sobre Certidumbre Regulatoria para el Sector Farmacéutico’ (Strategy of Regulatory Certitude for the Pharmaceutical Sector), published last January by COFEPRIS describes important working projects the agency [...]

2024-02-12T12:09:15+00:00November 1st, 2023|Tags: , , , |

CIRS RD Briefing 89 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2018-2022

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 [...]

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the pharma industry

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current [...]

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