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Pharmacovigilance services in Singapore

The Health Sciences Authority (HSA) and Pharmacovigilance Advisory Committee (PVAC) oversee the pharmacovigilance system in Singapore. PVAC is a team of experts from the fields of medicine, pharmacy, pharmacology, and forensic sciences specially appointed to assess the effects of adverse drug events and provides guidance for the regulatory action related to the enhancement of the safety of the products. Reporting of all serious events is mandatory for pharmaceutical companies by filling out the CIOMS I form and submitting it via online reporting or to the Vigilance and Compliance branch. Consumers are encouraged to report adverse events through their healthcare professionals. The HSA encourages healthcare professionals to report any adverse drug reactions related to the health products online or in manual forms for all health products except vaccines, vaccines, and medical device forms.

As a leading global contender, DDReg understand 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 Singapore 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 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 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, aggregate reporting as well as regulatory agency website monitoring
  • Utilizes a variety of in-house tools and databases for pharmacovigilance 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.

PV Services

  • Authoring/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 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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