Evidence map›Paper›PMID 38898937›Full record

ReviewFrontiers in medicine2024

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency.

Ivana Silva, Giulia Gabrielli, Juan Garcia Burgos, Isabelle Moulon, Gonzalo Calvo Rojas, Ulrich Jaeger, Rosa Giuliani

Abstract readReview
In one paragraph

Review in Frontiers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ivana SilvaEuropean Medicines Agency, Amsterdam, Netherlands.
Giulia GabrielliEuropean Medicines Agency, Amsterdam, Netherlands.
Juan Garcia BurgosEuropean Medicines Agency, Amsterdam, Netherlands.
Isabelle MoulonEuropean Medicines Agency, Amsterdam, Netherlands.
Gonzalo Calvo RojasDepartment of Clinical Pharmacology, Hospital Clinic Barcelona, Barcelona, Spain.
Ulrich JaegerMedizinische Universitsat Wien, Vienna, Austria.
Rosa GiulianiGuy's Hospital, London, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The article shows that the input given by healthcare professionals (HCPs) adds value to the regulatory processes surrounding the development, authorisation, and monitoring of a medicine, but is also an instrument for accountability, trust, mutual exchange as well as an insight into the public health issues that matter most to one of the key stakeholder groups the Agency works with. We highlight the role of HCPs in the EU regulatory process and take stock of the first 10 years of the Framework for Interaction with HCPs to describe how practises have evolved over this time to meet the goals of informing, consulting and improving trust in the EU regulatory system. We will analyse what led European Medicines Agency (EMA) to develop this framework through to the next steps and where the interaction might lead in the future.

Indexed as

European Medicines Agencyhealthcare professionals (HCPs)public Healthregulation of medicinesstakeholder engagement

Identifiers

PMID38898937
PMCPMC11186408

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.