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Pharmacovigilance Services in Philippines

Every side-effect that is reported improves the safety profile of the medicinal product or medical devices. Food and Drug Administration (FDA) of the Philippines-Pharmacovigilance section is the National Pharmacovigilance Centre that oversees reporting of suspected adverse drug reactions (ADRs) from various sources including, manufacturers, healthcare professionals, consumers, hospitals, and various public health programs. Adverse events (AE) can be reported by HCPs, other health professionals, consumers, and manufacturers via the “Online Adverse Drug Reactions Reporting” form by completing the form online or by downloading the form, filling in the details, and sending it via email or mail to the FDA. ADRs can also be reported via telephone. Once the reports are submitted, the reports are entered into the national database and follow-ups are initiated for any incomplete information. The Philippines FDA then evaluates the reports for any new risks to consider any need for action and take appropriate measures. Moreover, the use of traditional medicine is on a higher level in the Philippines, therefore most of the AEs are missed, and under-reported due to uncertainty.

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 Philippines 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 Processing & tracking sheets
  • Reconciliation process with customers
  • ", h32: "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)
  • 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.
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Other PV Services

  • Authoring & Review of PSMF, PV SOPs
  • 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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