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Wednesday, June 27 • 12:45pm - 1:15pm
#351: Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance

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Component Type: Session
Level: Intermediate
CE: IACET 0.50

Seating is limited
As for the Qualified Person for Pharmacovigilance in industry (QPPV), Competent authorities and EMA could ask patients’ and consumers’ organisations to appoint an official contact person for pharmacovigilance. Although this contact person for patients has no legal obligation and is not mentioned in the legislation it is very much needed to maintain trust and confidence in marketed medicines. This Contact Person, ‘the Vigil’, would be trained on how pharmacovigilance is organized in Europe and in Member State of interest, and would be the liaison between members of an organization or users of social networks, and national or European regulatory authorities, possibly also for industry (as a second step). A registry of Contact Persons will list all volunteers appointed by their national authorities or EMA. The Vigils will benefit from training by national authorities, EMA, and other patients’ training programmes. Examples of successful engagement of patients in pharmacovigilance will be collated and analyzed. An action plan has been defined and written engagement sought from interested parties. This will include a Code of Practices, a reflection on legal status, and core competencies for a job description with enough flexibility for all types of patients’ organisations. A future aim is to create a sustainable structure to host the initiative and there are ongoing discussions with CIOMS as part of a possible group examining patient’s role in pharmacovigilance.

Learning Objectives

Describe the role and training needed for named patient for PV; Debate pros and cons of named patient for PV and identify opportunities that this role can produce; Identify how to get involved and help promote this initiative.


Brian Edwards, DrMed


Patient Engagement in Pharmacovigilance
Herve Le Louet

avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Herve Le Louet

Herve Le Louet

President, Head of PV Coordination, CIOMS and APHP
Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate... Read More →

Wednesday June 27, 2018 12:45pm - 1:15pm EDT
Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session |   16: Content Hubs, Session