Pharmacovigilance Post-Marketing

PSMF Online

Services

  • QPPV acting on “sponsor Behalf” and “owner” of Pharmacovigilance System Master File ( PSMF) and whole management of role in strict collaboration with MAH
  • Local representative for AIFA on behalf of the client and acting as QPPV or/and  “QPPV Deputy“ with Back-up services 24 hours / 7 days
  • Use of GB Pharma Standard Operating Procedures (SOPs) and preparation/implementation the Regulatories ones for the client
  • Managing Spontaneous ADR (Local, from Library Search, Extra EU)
  • Literature screening (local/worldwide)
  • Renting of Validated Safety Database (in compliance with E2B R3 Ich HL7 standard)
  • Eudravigilance’s management on behalf of the client
  • Pharmacovigilance Audit
  • Database management of SAE / AE
  • Case entry into Eudravigilance – EMA Database via EV-Web and into Safety DB
  • Download of case from the RFN (Rete di Farmacovigilanza Nazionale – NPN  (National Pharmacovigilance Network) on behalf of the customer
  • Training of company personnel on Pharmacovigilance
  • PSUR’s (Periodic Safety Update Report) preparation
  • CCSI’s (Company Core Safety Information) preparation
  • Risk Management Plan preparation
  • ICSR’s medical evaluation
  • Signal detection on routinely basis

PHARMACOVIGILANCE SYSTEM

Mandatory for MAHs is to maintain always available the Pharmacovigilance System as de­fined in European Directive 2010/84/UE to harmonize and strengthen the conduct of pharmacovigilance activi­ties in the EU.Legal requirements are defined in Regulation 520/2012 and further supported by the guidance in Module II of the “Good Vigilance Practice”.

 

  • Qualified Person Responsible for Pharmacovigilance (QPPV) as principle contact point for the Competent Authorities available(24/7 on-call) for PV issues
  • Local QPPVservices Acts as a single point of contact for the local Health Authorities
  • ICSR management and submission
  • Enter and maintenance of information on Eudravigilance Medicinal Product Dictionary (XEVMPD)
preparing, maintaining and storing web-based hosted solution accessible over the internet at all time.
Expertise for extensive and continuous training processes to pharmacovigilance and non-pharmacovigilance staff
Writing RMPs, assessing risk benefit analysis, RMP maintenance, and in line with GVP module V
  • Setup, Renting and management of a E2BR3 validated safety database
  • systematic worldwide literature review of widely used reference databases (Medline-Embase)
  • monitor scientific and medical publications in local journals
  • MLM monitoring
  • EU GVP Module VII-compliant PSURs and DSURs.
  • Submission with the new EU Repository