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Pharmacovigilance Services in Morocco

The National pharmacovigilance system in Morocco consists of the National pharmacovigilance committee (CNP), National pharmacovigilance centre (CNPV), and National Technical centre (CTPV) at the Central Level. At the Regional level, it consists of a pharmacovigilance representative (CRPV) and lastly, it consists of all other members such as health professionals, pharmaceutical and healthcare products companies, and patients/consumers. CNP plays an advisory role regarding the decisions to be submitted to the Ministry of Health, CNPV oversees all the processing and management of the adverse drug reactions (ADR) including collecting and evaluating the ADR reports, maintaining the national database of the ADR reports received, coordinating with CNP for any potential signals/alerts, and participating in the risk minimization measures. Furthermore, CTPV provides all the technical assistance regarding scientific issues to the CNPV, conducts pharmacovigilance investigations whenever necessary and reports to the CNPV. The role of CRPV is to develop pharmacovigilance activities on the regional level, collect ADRs and maintain the ADR database from the hospitals, patients, and physicians within this region and report them to CNPV. Adverse event reporting is voluntary for patients/consumers. However, it is mandatory for healthcare professionals (HCP) and marketing Authorization holders (MAHs) to report all adverse events related to the products. All ADRs can be submitted through the yellow notification form which is available in both paper and online (website) format. Alternatively, adverse event reporting can be done via email, post, fax, and telephone.

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 Morocco 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 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, periodic safety update 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
  • 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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