SERVICES

Pharmacovigilance services in Latvia

The State Agency of Medicines (SAM) monitors pharmacovigilance and related activities in Latvia. From receipt and processing of ADR reports to finally submission in the European database to evaluation of signals, periodic safety update reports (PSURs), risk management plans (RMPs) and pharmacovigilance inspections, SAM oversees all important pharmacovigilance operations. Marketing authorization holders (MAHs) should report ICSRs of Latvia directly to the EudraVigilance Human Post Authorisation Module (EVPM) with the message receiver identifier EVHUMAN. MAHs must also appoint a responsible QPPV who lives and works within the European Union that would be responsible for the development and maintenance of a pharmacovigilance system. If the QPPV does not reside in Latvia, then MAHs should appoint a national level contact person for pharmacovigilance issues. The authority shall exchange information regarding pharmacovigilance issues (also on the adverse drug reactions) with the State Agency of Medicines and marketing authorisation holders in order to ensure effective functioning of the pharmacovigilance services.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Latvia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking safety signal monitoring
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Qualified Person for Pharmacovigilance QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Local Safety Responsible
  • PV Quality Management System Oversight
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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