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Pharmacovigilance Services in Jordan

Right from the beginning Jordan has considered pharmacovigilance as one of the primary roles and has taken various initiatives on pharmacovigilance services in Jordan. The Jordan Pharmacovigilance Centre (JPC) established in 2001 within the drug directorate/ Ministry of Health oversees the collection and evaluation of adverse drug reactions (ADR) reports of the pharmaceutical products that are marketed in Jordan. Other measures undertaken by JPC include encouraging the doctors and other health professionals to submit suspected ADRs to JPC, obliging marketing authorization holders (MAH) to report ADR-related information to JPC, and helping the general public by providing the ADR-related information through various means such as news bulletins and seminars. Jordon has developed the Yellow form from the International Yellow card to facilitate unified reporting of ADR reports. This form can be used by health professionals and the public to submit ADR reports. MAHs must report the ADR via the International CIOMS I form. However, despite these initiatives, Jordan still faces underreporting as one of the pharmacovigilance challenges along with poor PV awareness.

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 Jordan 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 plan pharmacovigilance
  • 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.
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Authoring & Review of PSMF, PV SOPs etc
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV Services and Deputy
  • 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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