PHARMACOVIGILANCE SERVICES IN CENTRAL AND EASTERN EUROPE

Access to a local regulatory partner and local QPPV services in Central and Eastern European countries is an essential pre-requisite to executing successful market entry and development. Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services in the CEE countries.

PHARMACOVIGILANCE AND DRUG SAFETY CONSULTING

With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant national health authorities.

For those involved in pharmaceuticals/medicines/drugs and medical devices, the pharmacovigilance service package comprises:

  • QPPV (Qualified Person Responsible for Pharmacovigilance) – 24/7 service
  • 24 hour cover of adverse event case processing and adverse event reporting
  • Follow up of individual case safety reports
  • Expedited adverse event reporting
  • Assistance for interaction with competent authorities and local healthcare professionals
  • Drug Safety services, including submission of PSUR (Periodic Safety Update Reports)
  • Safety Data Management
  • MLM (Medical Literature Monitoring)
  • Continuous update on national pharmacovigilance requirements
  • Risk management plan pharmacovigilance
  • Pharmacovigilance training of client’s sales force
  • Implementation of local SOPs
EU pharmacovigilance regulations require each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. Grove provides a network of local QPPV (Qualified Person Responsible for Pharmacovigilance) experts in Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Estonia, Lithuania, Serbia, Montenegro and Russia as a solution for pharmacovigilance issues at a national level. These highly skilled and continuously trained professionals provide a full range of pharmacovigilance and medical device vigilance services to enable Grove clients to maintain compliance with EU drug safety and pharmacovigilance requirements.

Moreover, our pharmacovigilance activities at a national level cover the following areas:

  • Assistance for interaction with Competent Authorities in the country
  • Assistance for interaction with Ethical Committees in the country
  • Continuous update on the national pharmacovigilance and regulatory requirements
  • English translations of local regulations and/or Competent Authorities communication in the country (letters, emails, fax), when available only in local languages.
  • Most importantly, pharmacovigilance services at a national level ensure patient safety, fulfilment of all local and national regulatory requirements and general compliance with current international guidelines for Good Pharmacovigilance Practices.