Ensure Compliance. Enhance Patient Safety With Pharmacovigilance Services
It is mandatory to have a pharmacovigilance system in place to ensure the continuous monitoring of medicinal products and medical devices for their safe use. The Canada Vigilance Program is Health Canada’s pharmacovigilance program responsible for collecting and assessing adverse drug reaction reports for health products. Health care professionals, patients/consumers, manufacturers, and distributors can submit the adverse drug reaction (ADR) reports directly to Health Canada or Marketing Authorization holders.
Mivado GlobalPerformance understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Canada, we provide end-to-end pharmacovigilance services in Canada that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans by the local requirements and good pharmacovigilance practices.
Mivado GlobalPerformance 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 DB) and MedDRA
- Quality Check, Medical reviews
- Submission of cases as per agency timelines
- Maintaining ICSR Processing and tracking sheets
- Reconciliation process with customers
Risk Management Plan
- Drafting, reviewing, and maintaining RMPs and 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 labeling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)
Signal Management
- Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from the ICSR database, Literature Monitoring, aggregate reports, as well as regulatory agency website monitoring.
- Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes.
- Reviews safety signals for ICSRs, aggregate reports, and recommendations by the Pharmacovigilance Risk Assessment Committee (PRAC).
- Performs label update analysis
- Provide recommendations from signal assessments, which include risk minimization approaches
- Preparation of Signal Management Tracker and Annual Signal Reports.
Aggregate Reports
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Report (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
QPPV Services
- Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs, etc.
- Review & sign off on Aggregate reports, Signal Reports, and RMPs
- Retainer services for QPPV and Deputy
- 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 or mock audits to prepare customer organizations for PV inspections conducted by the respective competent authorities.
- Conduct regular gap assessments of PV staff at the site location
- Provide organizational training on safety audits and inspections
Mivado GlobalPerformance offers comprehensive pharmacovigilance services in Canada, including adverse drug reaction reporting, signal detection and management, aggregate report writing, and customized pharmacovigilance plans. Our commitment to patient safety extends from clinical trials to post-marketing surveillance, ensuring compliance with local regulations and pharmacovigilance best practices.
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