Concepedia

Standard Harmonization

Standard Harmonization is a regulatory framework that establishes uniform technical specifications and criteria across jurisdictions to ensure consistent evaluation, approval, and oversight of medical devices while facilitating international compliance and interoperability.

58

Publications

3.2K

Citations

204

Authors

139

Institutions

Publications per year

2017–2026

14

Parents

Publications

58

THE INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICE GUIDELINE

Quality Assurance · 1999 · 508 citations

, , +13

International Conference on Harmonization (ICH)

Jen‐pei Liu, Shein‐Chung Chow · 2018 · 427 citations

, , +10

Guidelines from the International Conference on Harmonisation (ICH)

Sarah K. Branch · Journal of Pharmaceutical and Biomedical Analysis · 2005 · 327 citations

, , +9

ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group.

PubMed · 1999 · 313 citations

, , +11

The New Approach to Technical Harmonization and Standardization

Jacques Pelkmans · JCMS Journal of Common Market Studies · 1987 · 226 citations

, , +11

1–5 of 58

Authors

204

  1. WS
    Walter Steingress

    Bank of Canada, Canada

    2 publications · 56 citations

    2

    h-index

  2. MP
    Mauro Panteghini

    University of Milan, Italy

    2 publications · 106 citations

    2

    h-index

  3. JS
    Julia Schmidt

    Banque de France, France

    2 publications · 56 citations

    2

    h-index

  4. MP
    Mario Plebani

    University of Padua, Italy

    2 publications · 94 citations

    2

    h-index

  5. PR
    Pierre Roy

    Sony Computer Science Laboratories, Japan

    1 publications · 18 citations

    1

    h-index

1–5 of 204

Institutions

139

  1. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    2 publications

    69 citations

  2. Bank of Canada

    Ottawa, Canada

    2 h-index

    2 publications

    56 citations

  3. University of Exeter

    Exeter, United Kingdom

    2 h-index

    2 publications

    42 citations

  4. University of Padua

    Padua, Italy

    2 h-index

    2 publications

    94 citations

  5. Banque de France

    Paris, France

    2 h-index

    2 publications

    56 citations

  6. Pharmaceuticals and Medical Devices Agency

    Tokyo, Japan

    2 h-index

    5 publications

    107 citations

  7. Université Claude Bernard Lyon 1

    Villeurbanne, France

    2 h-index

    2 publications

    52 citations

  8. University Medical Center Groningen

    Groningen, The Netherlands

    1 h-index

    3 publications

    264 citations

1–8 of 139

Venues

  1. Clinica Chimica Acta

    CCA · 4 publications · 131 citations

    4

    h-index

  2. PubMed

    Repository · 4 publications · 379 citations

    4

    h-index

  3. 3

    h-index

  4. Abacus

    2 publications · 98 citations

    2

    h-index

  5. Journal of Food Composition and Analysis

    1 publications · 14 citations

    1

    h-index

1–5