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Pharmacovigilance Services in Jordan

Compliance with Advanced Jordan Pharmacovigilance Regulations

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.

Why Choose DDReg for Pharmacovigilance in Jordan?

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 in Jordan Includes:

ICSR Processing and Submission

Risk Management Plan

Aggregate Reports

Signal Management

QPPV Services in Jordan

  • 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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