SERVICES

Pharmacovigilance Services in Canada

In Canada, it is mandatory to have a pharmacovigilance system to assure continuous monitoring of medicinal products and medical devices for their safe use. The Canada Vigilance Program is Health Canada’s pharmacovigilance program that is accountable for collecting and assessing the adverse drug reaction reports of health products. Anyone including health care professionals, patients/consumers, manufacturers, and distributors can submit the adverse drug reaction (ADR) reports directly to Health Canada or to Marketing Authorization holders. There are seven regional offices of Canada Vigilance which act as regional points of contact for the health professionals and support The Canada Vigilance Program to collect reports from these regions which are further forwarded to the Canada Vigilance National Office for further analysis. In addition to this Canada maintains Canada Vigilance Online Database for all the suspected adverse drug reaction reports.

As a leading global contender, DDReg 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 in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • CCase Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR Processing & 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 labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) (PIL)

Aggregate Reports

  • Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Periodic Safety Update Report (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from 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 Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etcs
  • Review & sign off of 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 as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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