Evidence map›Paper›PMID 39502880›Full record

ArticleTherapeutic advances in drug safety2024

The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey.

Lisa Stagi, Ilenia Bocchi, Daniela Bernardini, Marika Ciappa, Stefania Dellon, Gian Nicola Castiglione, Silvia Romano, Eros Fabrizi, Amanda Mattavelli, Ilaria Grisoni and 2 more

Abstract read
In one paragraph

Article in Therapeutic advances in drug safety, 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

12 authors.

Lisa StagiRoche S.p.A., Monza, Italy.
Ilenia BocchiBayer S.p.A., Milano, Italy.ORCID https://orcid.org/0000-0001-5762-2466
Daniela BernardiniNovartis Farma S.p.A., Viale Luigi Sturzo, n. 43, Milano 20154, Italy.ORCID https://orcid.org/0009-0003-7689-5488
Marika CiappaAstraZeneca S.p.A., Rho, Italy.
Stefania DellonIdorsia Pharmaceuticals Italy S.r.l., Milano, Italy.
Gian Nicola CastiglioneFree Lance, Pharmacovigilance Consultant, Italy.
Silvia RomanoSanofi S.r.l., Milano, Italy.
Eros FabriziRhythm Pharmaceuticals, Roma, Italy.
Amanda MattavelliJohnson & Johnson Innovative Medicine, Milano, Italy.
Ilaria GrisoniJazz Pharmaceuticals, Villa Guardia, Italy.
Gabriella FiniziaFree Lance, Pharmacovigilance Consultant, Verona, Italy.
Stefano BonatoFree Lance, Pharmacovigilance Consultant, Lissone, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem. Since its inception in the 1960s, PV has undergone continuous evolution, progressing from a basic level mainly focused on the collection and analysis of cases in its earliest years to a complex system regulated by rigorous standards and laws with modern PV. In recent years, PV has faced the challenge of adapting to rapid scientific advancements, the complexity of the pharma industry, and the digital revolution. To better understand the current state and future developments of PV within pharma companies, the PV working group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF ETS) conducted a national survey in Italy. Objectives: The main objective of this survey was to explore the current state and future developments of PV within Pharmaceutical Companies in Italy. Design: This study was designed as a national survey targeting members of the Italian Society of Pharmaceutical Medicine (SIMeF ETS). Methods: The survey utilized computer-assisted web interview (CAWI) technology to collect data from SIMeF members across affiliate and corporate companies, aiming to explore expectations for PV. A simplified version of the questionnaire was also sent to members of the Clinical Research and Medical Affairs (RICMA) and Real-World Evidence working groups of SIMeF to gather input from RICMA professionals regarding the role of PV in pharma companies. Results: The survey revealed that PV in pharma companies is undergoing a transformation, with the potential for greater strategic alignment with business objectives and stakeholder focus. However, there is still room for improvement, particularly in terms of perception within other company departments. It is evident that PV's evolution has only just begun. Conclusion: A critical factor in the evolution of PV is the adoption of a holistic and comprehensive approach to activities and processes. Scientific associations such as SIMeF can play a valuable role in cultivating new skills and capabilities among PV professionals, assisting, and supporting this change.

Indexed as

innovationpatient centricitypharmacovigilance

Identifiers

PMID39502880
PMCPMC11536373

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.