DIA 2018 Global Annual Meeting

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.

Chair

Brian Edwards, DrMed

Speaker

Patient Engagement in Pharmacovigilance
Herve Le Louet