jsharpe

About Jenny Sharpe

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So far Jenny Sharpe has created 141 blog entries.

Improving development, regulatory and reimbursement frameworks for rare disease products

This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]

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 [...]

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 [...]

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