Posters

Good Review Practices at the Zambian Medicines Regulatory Authority

Good Review Practices (GRevPs) are an important component of regulatory systems strengthening and support progress in World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment. This poster was presented [...]

2026-08-18T09:26:03+00:00August 19th, 2026|Tags: , , |

African Medicines Agency (AMA): Origins, Evolution and Future Prospects

This poster was presented at DIA 2026 and examines the development of the African Medicines Agency (AMA), tracing its evolution from the African Medicines Regulatory Harmonisation (AMRH) Programme to its [...]

2026-08-03T11:06:26+00:00August 6th, 2026|Tags: , , |

Examining the UK HTA Landscape for Orphan Medicines

To mark Rare Disease Day on 28 February, we’re sharing findings from our work examining how orphan new active substances (NASs) are assessed by two of the UK’s HTA [...]

2026-02-25T11:45:23+00:00February 26th, 2026|Tags: , , , |

Canadian HTA landscape: Comparing HTA timelines and outcomes for CDA-AMC and INESSS

How do HTA timelines and recommendations compare across Canada’s HTA agencies? At ISPOR Europe 2025, we presented a poster analysing HTA timelines and outcomes for Canada's Drug Agency (CDA‑AMC) [...]

2026-01-20T17:08:47+00:00January 21st, 2026|Tags: , |

HTA Submission Trends for EMA-Approved Oncology Medicines 2018-2023

How quickly do oncology medicines move from EMA approval to HTA submission across Europe — and how might this change under the EU HTA Regulation? At ISPOR Europe 2025, [...]

2026-01-07T16:23:29+00:00January 7th, 2026|Tags: , , , , |

Testing the UMBRA benefit-risk tool in a South African agency

Objectives Regulators must balance medicine benefits and risks while ensuring consistency, transparency, and efficiency in decision-making and the aim of this study was to assess UMBRA’s impact on SAHPRA [...]

2026-02-05T14:42:56+00:00July 2nd, 2025|Tags: , , , |

Assessing Good Review Practices at the FDA Ghana

Objectives To identify the current perspective of the FDA Ghana in the implementation of Good Review Practices, provide a baseline on the knowledge, attitudes, practices, as well as identify [...]

2026-02-05T14:43:08+00:00July 2nd, 2025|Tags: , , |

Proposed Model for EAC MRH Joint Review

Objectives 1. To investigate ways in which the regional initiative could be well coordinated.2. To propose an improved model for the East African Medicine Regulatory Harmonisation Initiative joint assessments.3. [...]

2026-02-05T14:43:36+00:00July 2nd, 2025|Tags: , , , |

Evaluating Quality of Decision Making within the Zambia Medicines Regulatory Authority

Objectives To assess the quality of the decision-making process followed by regulatory reviewers, explore their perceptions of the Zambia Medicines Regulatory Authority (ZAMRA) decision-making approach, and evaluate the usefulness [...]

2025-12-09T14:54:16+00:00July 2nd, 2025|Tags: , , , |

Frequency and Variation of Clock-Stop During EMA Assessment for Oncology Products – Implication on JCA Timelines

Objectives: The implementation act adopted for the HTA Regulation (HTAR) defined the timelines of scoping, submission and assessment and output of Joint Clinical Assessment (JCA), which will be in [...]

2025-12-09T15:06:32+00:00November 28th, 2024|Tags: , , , |
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