Pharmacovigilance Services

Product Information, marketing authorisations, variations, renewals, withdrawal, regulatory intelligence, legislation scanning, medicines authority, pharmacovigilance, EU QPPV, adverse event reporting, side effects, out of office hours contact, 24x7, medical enquiry, complaints, literature review, audits, inspections, capa, risk minimisation measures, quality management system, qms, quality risk management, qrm, direct healthcare professional communication, dhpc, periodic safety update report, psur, developmental update safety report, dsur, monthy reconciliation, quality assurance, quality control, Good vigilance practice, gvp, internal audits, training, deviation, local representative, change control, mah, marketing authorisation holder, IT validation, Business Continuity Plan, BCP, Gap analysis, support, Malta, Standard operating procedures, SOP, Quality Manual, Quality Policy, Work Instruction, Controlled documents, medical devices, Medical Device Regulation, MDR, 2017/745, iso certification, iso 9001:2015, In vitro diagnostic, IVDR, 2017/746, labelling, artwork, mock up.
Collecting Pharmacovigilance safety information through various sources such as medical and scientific literature screening

We can provide our specialised support to Marketing Authorisation Holders (MAHs) to meet the Good Pharmacovigilance Practice (GVP) Guidelines through various activities including:

    • Proper maintenance of the Pharmacovigilance System Master File (PSMF) by maintaining awareness of current regional and local regulations and guidelines by legislation scanning and evaluating impact on current MAH processes
    • Taking over the EU Qualified Person for Pharmacovigilance (QPPV) and EU QPPV deputy roles or alternatively supporting the established EU QPPV by acting as the national local responsible person for Pharmacovigilance in Malta
    • Ensuring a functioning Pharmacovigilance system is in place for both business hours and out of hours collection of adverse events, medical information enquiries, complaint reports and special situation reports such as administration during pregnancy and breastfeeding, paediatric exposure, lack of effect, overdose, medication error, drug abuse or misuse, off-label use, occupational exposure and suspected transmission of infectious agents
    • Taking care of the data collection from various sources such as literature review of local journals, local Health Authority publications, spontaneous reports, solicited reports, clinical studies and monitoring of social media and forwarding all acquired relevant safety information to the MAH
    • Performing monthly reconciliations of adverse events, medical information enquiries and Complaint Reports with the relevant departments at the MAH site
    • Compilation and regulatory submission of Risk Management Plans (RMPs) and subsequent implementation of applicable Risk Minimisation Measures (RMMs) such as Direct Healthcare Professional Communications (DHPCs), Pregnancy Prevention Plans (PPP) or educational materials for doctors, pharmacists and patients
    • Preparing and submitting Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
    • Training personnel on Pharmacovigilance awareness and proper handling and reporting of drug safety cases
    • Providing our advice and support to MAHs while preparing for Pharmacovigilance Inspections and in the subsequent creation of necessary Corrective and Preventive Actions and their effective implementation
    • Assisting in the creation, implementation and maintenance of crisis management procedures to ensure continuity of the critical and essential pharmacovigilance activities as required by GVP Guidelines
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