Pharmacovigilance Post-Marketing
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”.
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