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Pharmacovigilance Services in Australia

Reporting adverse drug reactions (ADRs) to the responsible authorities is directly proportional to patient safety. In Australia, the Therapeutic Goods Administration (TGA) oversees reporting of ADR related to medicines and medical devices. Anyone including the public, general practitioners, nurses, other health professionals and the therapeutic goods industry can report ADRs either online through the Australian Adverse Drug Reactions Reporting System or via telephone, post, fax, and email. Whether or not the ADR is confirmed, the TGA assess the causality of that suspected ADR. It is voluntary for the clinicians and the public to report the ADR; however, it is mandatory for the sponsors of both registered and listed drugs to report all the suspected ADRs to the TGA. The main areas of interest for TGA include adverse events related to newly listed or registered drugs, medicine or vaccine interactions, the suspected adverse event not listed in product information or in medical resources, and adverse events leading to death, admission to hospital, prolonged hospitalization, or birth defects. Australia has two databases of adverse event notifications (DAEN) namely, DAEN-medicines and DAEN-medical devices. DAEN-medicines provide information on the adverse events related to medicines and vaccines and DAEN-medical devices provide information on the adverse events related to medical devices used in Australia. One of the challenges that TGA may face is underreporting of the side-effects and non-availability of the comorbidities data, thus limiting the contributory and confounding factors to an adverse event.

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 for Australia, we provide end-to-end Pharmacovigilance Services in Australia 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 services
  • 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, pharmacovigilance aggregate reporting 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.

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 and Deputy
  • Monthly reconciliation
  • 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
  • Conduct regular gap assessments of PV staff at site location.
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Provide organizational training on safety audits and inspections
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