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
In a constantly evolving Healthcare environment and with patients able to always have more information about their diseases and therapeutic pathways, the Patient Support Programs (PSP) have acquired a fundamental importance in managing the diagnostic / therapeutic path in the best way, managing the differences between the various patients and their expectations. Designing and conducting PSPs becomes essential to support the patient to correctly follow a therapy, reduce the movement of the same from his home, to use health resources more correctly.
GB Pharma proposes itself as a partner in the analysis of the needs and design of PSP with an adequate cost / effectiveness ratio.
GB Pharma is also able to ensure compliance with Pharmacovigilance associated with PSPs in accordance with the Italian and European legislation.
The Market Research covers a wide range of investigations aimed at studying and understanding the motivations, the desires, the expectations of patients and doctors in the management of the disease and related therapies. The MRs include focus groups with doctors or patients, investigations on the perception of the pathology, on the motivations that could lead to choose a therapeutic path rather than another.
GB Pharma is a partner in the planning and design of MR and is also able to ensure every compliance of Pharmacovigilance associated with MR in accordance with Italian and European legislation.