Pharmacovigilance in European Union

Pharmacovigilance as a definition is a science and all activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

 

The safety of all medicines has to be monitored throughout their use in healthcare practice. 

After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. 

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area (EEA). 

EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. 

Clinical Consulting provide services of qualified staff involved in EudraVigilance reporting:
 

  1. Pharmacovigilance System Setting

  • Creation and implementation of a pharmacovigilance system compliant to the latest Good Pharmacovigilance Practices

  • Writing of SOPs and PSMF

  • Creation of documents specific to the product and trial in order to ensure the work is done / track in accordance with GVP (in case of audit)

  2. EudraVigilance activities

  • Registration of Sponsor  (must be done by an appointed 'Responsible Person for Pharmacovigilance' who must be appropriately qualified

  • Creation of the Drug Substance and the Drug Product (xEVMPD)

    • this is needed to fulfill the European clinical trial application form

    • to be done when Sponsor is registered in EudraVigilance

  3. Individual cases management

  • Collection and evaluation of the European cases (according to EU Good Pharmacovigilance Practices), managing follow-up of cases (if information are missing to get a 'valid' case)

  • Coding in EudraVigilance database and handling submission of adverse events to European Competent Authorities,  Ethic Committees, Investigators (in accordance with national requirements)

  • Providing European cases (for example to IND2R) on xml format, in order to be uploaded in DSUR (Development Safety Update Report) - written annually

  • PV system update due to change of the Good Pharmacovigilance Practices

  • Literature review and evaluation

  • Audit from authorities

  • Any other business activities

Important sites:

EudraVigilance overview

New EudraVigilance website
Polish Database of suspected adverse events