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Pharmacovigilance services in South Korea

The Korea Institute of Drug Safety and Risk Management (KIDS) is responsible for the identification and prevention of drug-related issues in South Korea and functions under the Ministry of Food and Drug Safety of South Korea (MFDS). KIDS mainly focuses on awareness regarding adverse drug event reporting, investigating the adverse event (AE) information and assessing the causality, developing drug utilization review (DUR) criteria, and percolating this information to the general public. To further ease this process, KIDS has developed a reporting and management system called The Korea adverse event reporting system (KAERS). All the adverse event reports information is stored in KAERS in the form of individual case safety reports (ICSR). Anyone can report AE including the general public, physicians, other health professionals, regional pharmacovigilance centres (RPVC), and market authorization holders (MAH) can report via ADR call centre, fax, and email. The RPVCs are responsible for the assessment of causality for their centres in their regions and further report this to the KAERS. Similarly, pharmaceutical manufacturers submit the report via KAERS, especially in mandatory reporting required by the regulation. In addition to this reporting of foreign ADRs has been mandated for more comprehensive safety information.

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, we provide end-to-end pharmacovigilance services in South Korea 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,
  • Case 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 monitoring & 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 services
  • 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)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • 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, pharmacovigilance aggregate reporting as well as regulatory agency website monitoring 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
  • Performs label update analysis
  • Preparation of Signal Management Tracker, Annual Signal Reports.

PV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • 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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