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Drug Safety

pp 1–5 | Cite as

Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives

  • Janet Sultana
  • Ugo Moretti
  • Antonio Addis
  • Pia Caduff
  • Annalisa Capuano
  • Agnes Kant
  • Joan-Ramon Laporte
  • Marie Lindquist
  • June Raine
  • Daniele Sartori
  • Gianluca Trifirò
  • Marco Tuccori
  • Mauro Venegoni
  • Eugene van Puijenbroek
  • Roberto LeoneEmail author
Meeting Report
  • 44 Downloads

Introduction

The field of pharmacovigilance has evolved significantly since the turn of the millennium, from spontaneous reporting to complex pharmacoepidemiologic studies, to the implementation of new methodologies for proactive pharmacovigilance and risk minimisation measures and, more recently, the attempts to use big data for post-marketing drug safety assessment [1]. Pharmacovigilance in Italy is no exception to such progress; the quality and quantity of spontaneous reporting have improved significantly, the number of centres of excellence dedicated to pharmacoepidemiology and pharmacovigilance has increased notably, partnerships and collaborations with Regional Pharmacovigilance Centres are being consolidated and the presence of pharmacovigilance experts at the Italian Drug Agency has increased [2, 3]. The availability of funding for pharmacovigilance, partly dedicated to the running of regional pharmacovigilance centres and partly dedicated to funding regional and...

Notes

Acknowledgements

The authors would like to thank all the other attendees of the workshop: Elena Arzenton, Gian Nicola Castiglione, Paola Cutroneo, Alessandra Del Porto, Armando Gennazzani, Carmen Ferrajolo, Olivia Leoni, Lorella Lombardozzi, Nadia Mores, Francesca Menniti-Ippolito, Pietro Minuz, Concetta Rafaniello, Carmela Santuccio, Giovanna Scroccaro, Liberata Sportiello, and Francesco Trotta. The authors would like to acknowledge the contribution of Cosimo Zaccaria to the writing of the paper. The authors would also like to acknowledge with gratitude the great contribution of Prof. Gianpaolo Velo, who passed away in 2017, to pharmacovigilance in Italy.

Author contributions

Writing and revision of the manuscript: Janet Sultana, Ugo Moretti, Antonio Addis, Pia Caduff, Annalisa Capuano, Agnes Kant, Joan-Ramon Laporte, Marie Lindquist, June Raine, Daniele Sartori, Gianluca Trifirò, Marco Tuccori, Mauro Venegoni, Eugene van Puijenbroek and Roberto Leone.

Compliance with Ethical Standards

Funding

The authors were not funded for their contribution to the present paper.

Conflict of interest

Janet Sultana, Ugo Moretti, Antonio Addis, Pia Caduff, Annalisa Capuano, Agnes Kant, Joan-Ramon Laporte, Marie Lindquist, June Raine, Daniele Sartori, Gianluca Trifirò, Marco Tuccori, Mauro Venegoni, Eugene van Puijenbroek and Roberto Leone have no conflicts of interest related to the present manuscript to declare. The present study was not funded, nor were the authors financially or otherwise compensated for their contribution to the present report.

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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Janet Sultana
    • 1
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  • Ugo Moretti
    • 2
  • Antonio Addis
    • 3
  • Pia Caduff
    • 4
  • Annalisa Capuano
    • 5
  • Agnes Kant
    • 6
  • Joan-Ramon Laporte
    • 7
  • Marie Lindquist
    • 4
  • June Raine
    • 8
  • Daniele Sartori
    • 4
  • Gianluca Trifirò
    • 1
  • Marco Tuccori
    • 9
  • Mauro Venegoni
    • 2
  • Eugene van Puijenbroek
    • 6
  • Roberto Leone
    • 2
    Email author
  1. 1.Department of Biomedical and Dental Sciences and Morphofunctional ImagingUniversity of MessinaMessinaItaly
  2. 2.Veneto Regional Pharmacovigilance CentreUniversity of VeronaVeronaItaly
  3. 3.Department of EpidemiologyLazio Regional Health ServiceRomeItaly
  4. 4.Uppsala Monitoring CentreUppsalaSweden
  5. 5.Campania Pharmacovigilance Regional CentreNaplesItaly
  6. 6.Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting‘s HertogenboschThe Netherlands
  7. 7.Fundació Institut Català de Farmacologia, Hospital Vall d’HebronAutonomous University of BarcelonaBarcelonaSpain
  8. 8.Medicines and Healthcare products Regulatory AgencyLondonUK
  9. 9.Toscana Pharmacovigilance Regional CentrePisaItaly

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