SERVICES

Pharmacovigilance services in UAE

The pharmacovigilance landscape in the UAE is one that is rapidly developing to ensure patient safety. The Ministry of Health and Prevention (MOHAP) oversees all activities within UAE’s healthcare system including pharmacovigilance. Each Emirate has appointed a national healthcare authority that is responsible for monitoring the respective healthcare system. pharmacovigilance guidelines that are followed are based on those of the EU GVP and Arab GVP which dictates requirements for PSMFs, RMPs, ICSRs, PSURs/PBRERs, signal detection as well as QPPV. Marketing Authorization Holders must appoint a local QPPV that holds UAE residency. Foreign pharmaceutical organizations who have a local UAE agent must have a local safety responsible person that lives in the UAE, and should ideally be a physician or pharmacist. The MOHAP also requires a National Pharmacovigilance File that has additional information on ADRs, PSURs and RMPs. Healthcare professionals and patients submit their ADR reports to the MOHAP which can be in paper form, via emails, or through ‘smart applications’. Furthermore, all ICSRs and any data the provides insight to the safety profile of a pharmaceutical product, which could impact patient safety, must be submitted to MOHAP as soon as possible. The MOHAP is active in implementing a robust pharmacovigilance system to safeguard public health by offering various services. For example, the MOHAP website provides services for ‘Approval of Pharmacovigilance Officer of Pharmaceutical Facility’ and ‘Evaluation of Pharmacovigilance Plan for Pharmaceutical Facility and its Subsidiaries

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 UAE 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 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)
  • 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 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, and Annual Signal Reports.

Responsible Person for Pharmacovigilance (RPPV)/QPPV Services

  • 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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