Pharmacovigilance and QPPV

Safety of medicinal products is one of the main responsibilities during clinical development and after registration.  Pharmacovigilance is a science of collecting, monitoring, evaluating an information from various healthcare providers and patients regarding the adverse events of medicinal products, gathering information about reported side effects and thereby preventing future risk of causing harm to patients.

Pharmacovigilance issues are regulated by the European Parliament and European Council Regulations No.1235/2010 and Directive 2010/84/EU and an implementing regulation Commission implementing regulation No 520/2012.

Medlex Baltics has a well-trained staff in pharmacovigilance services including a Qualified Person for Pharmacovigilance (QPPV) in order to perform the mandatory reporting of (early) clinical trials to authorities, ethical committees and investigators.

SAE Management and reporting

The pharmacovigilance services of Medlex Baltics include all aspects of safety management related to processing of Serious Adverse Events (SAE) and (Serious) Adverse Drug Reaction (ADR) reports (SUSARs) for clinical research trials within the EU.
The pharmacovigilance services provided by Medlex Baltics include:

  • acting as local contacr persons for authorities
  • 24/7 medical and safety presence
  • Pharmacovigilance training to trial personne
  • SAE/ADR management: Daily receipt & acknowledgement, data-entry, medical review
  • Expedited Reporting: Medlex Baltics sends the reports  via EU EudraVigilance Web
  • Search of Literature

QPPV services

According to European laws, Marketing Authorisation Holders (MAHs) are required to appoint a QPPV (Qualified Person for Pharmacovigilance) and a deputy QPPV residing in the EEA. We are offering this  responsibility including the 24/7 availability.

It is mandatory to always prepare a pharmacovigilance service agreement, clearly setting the taks and responsibilities and fulfilment thereof prior to taking the responsibility of QPPV.

Periodic Safety Reports

Medlex Baltics also can prepare the safety reports for sponsors, including

  • Safety Risk Management Plans (RMP)
  • Periodic Safety Update Reports incl. a benefit –risk section.
  • Annual Safety Reports and Drug Safety Update Reports (ASRs/ DSURs)