Concepedia

Pharmacovigilance Harmonization

Pharmacovigilance Harmonization is a regulatory science framework that standardizes drug safety monitoring, data collection, and risk assessment methodologies across jurisdictions to ensure consistent, timely, and interoperable detection and management of adverse drug reactions globally.

53

Publications

2K

Citations

315

Authors

225

Institutions

Publications per year

2017–2026

23

Parents

Publications

53

OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

Ruwen Böhm, Leocadie von Hehn, Thomas Herdegen et al. · PLoS ONE · 2016 · 254 citations · Full text

, , +16

International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

PubMed · 2010 · 150 citations

, , +14

Worsening and newly diagnosed paraneoplastic syndromes following anti-PD-1 or anti-PD-L1 immunotherapies, a descriptive study

Guillaume Manson, Alexandre Maria, F. Poizeau et al. · Journal for ImmunoTherapy of Cancer · 2019 · 106 citations · Full text

, , +17

Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania

Abbie Barry, Sten Olsson, Omary Minzi et al. · Drug Safety · 2020 · 67 citations · Full text

, , +17

Clinical features and correlates of gemcitabine‐associated lung injury

Steven M. Belknap, Timothy M. Kuzel, Paul R. Yarnold et al. · Cancer · 2006 · 66 citations · Full text

, , +14

1–5 of 53

Authors

315

  1. MP
    Mauro Panteghini

    University of Milan, Italy

    2 publications · 106 citations

    2

    h-index

  2. MO
    Margaret Oluka

    University of Nairobi, Kenya

    2 publications · 87 citations

    2

    h-index

  3. CL
    Charles L. Bennett

    Northwestern University, United States

    2 publications · 128 citations

    2

    h-index

  4. AN
    Anastasia N Guantai

    University of Nairobi, Kenya

    2 publications · 87 citations

    2

    h-index

  5. EA
    Eleni Aklillu

    Karolinska Institutet, Sweden

    2 publications · 87 citations

    2

    h-index

1–5 of 315

Institutions

225

  1. Inserm

    Paris, France

    4 h-index

    27 publications

    614 citations

  2. World Health Organization

    Geneva, Switzerland

    3 h-index

    4 publications

    118 citations

  3. Karolinska Institutet

    Stockholm, Sweden

    3 h-index

    9 publications

    375 citations

  4. Karolinska University Hospital

    Stockholm, Sweden

    3 h-index

    9 publications

    375 citations

  5. Netherlands Pharmacovigilance Centre Lareb

    's-Hertogenbosch, The Netherlands

    3 h-index

    4 publications

    117 citations

  6. Service de la Santé Publique

    Fribourg, Switzerland

    2 h-index

    3 publications

    230 citations

  7. University of Nairobi

    Nairobi, Kenya

    2 h-index

    4 publications

    174 citations

  8. Centre National de la Recherche Scientifique

    Paris, France

    2 h-index

    2 publications

    124 citations

1–8 of 225

Venues

  1. PubMed

    Repository · 5 publications · 244 citations

    5

    h-index

  2. Drug Safety

    5 publications · 196 citations

    5

    h-index

  3. PLoS Medicine

    2 publications · 40 citations

    2

    h-index

  4. Expert Opinion on Drug Safety

    2 publications · 32 citations

    2

    h-index

  5. Clinical Pharmacology & Therapeutics

    CPT · 2 publications · 88 citations

    2

    h-index

1–5