SERVICES

Pharmacovigilance services in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulatory and pharmacovigilance operations in the UK. Patient safety is the core of all pharmacovigilance Solutions where timely detection and management of ADRs is imperative in order to implement effective risk mitigation/minimization strategies. For medicines which are authorised nationally in the UK, a Marketing Authorisation Holder (MAH) must submit the necessary pharmacovigilance data to the MHRA such as UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post-Authorisation Safety Studies (PASS) protocols and final study reports. The MAH shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (QPPV). If the UK QPPV is not based in the United Kingdom, a National Contact Person for Pharmacovigilance (NCPP) must be based in the United Kingdom for any immediate enquiries. MHRA promotes safe medication use through prevention, identification, analysis, management and documentation of adverse effects and drug-related problems

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in UK 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 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)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • 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, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking safety signal monitoring
  • 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.

UK Qualified Person for Pharmacovigilance (UK QPPV)/ National Contact Person for Pharmacovigilance (NCPP)

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV Services and Deputy
  • Local Safety Responsible
  • 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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