Pharmacovigilance Services in Morocco

If you're a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Morocco, explore DDReg’s pharmacovigilance services to ensure drug safety and regulatory compliance. From adverse drug reaction (ADR) reporting to compliance with Morocco's pharmacovigilance regulations, the right pharmacovigilance partner shapes everything including signal detection, risk management planning, safety reporting, and successful market authorization.

As a leading global contender, DDReg understands the significance of patient safety 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 ADR reporting, signal detection & management, aggregate report writing, and the development of customized pharmacovigilance plans/ risk management plans in accordance with local requirements and good pharmacovigilance practices.

Navigating the complexities of pharmacovigilance in Morocco requires a trusted partner with local expertise and global standards. DDReg offers comprehensive pharmacovigilance services tailored to meet the regulatory requirements of Morocco, ensuring patient safety and compliance throughout the product lifecycle.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases integrated with WHO Drug Dictionary and MedDRA
  • Quality checks and medical reviews
  • Submission of cases per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • 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, preparing 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 conveying risks through labeling means such as Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Report (PSURsF )
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of 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
  • Providing recommendations from signal assessments, including risk minimization approaches
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + Local Pharmacovigilance Services in Morocco
  • Authoring & reviewing of Pharmacovigilance System Master File (PSMF), Pharmacovigilance Standard Operating Procedures (PV SOPs)
  • Monthly reconciliation
  • Medical review of signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly communication reports/provision of compliance metrics
  • PV Quality Management System Oversight
• + PV Quality Management & Compliance
  • Authoring & reviewing of Pharmacovigilance System Master File (PSMF), Pharmacovigilance Standard Operating Procedures (PV SOPs)
  • Monthly reconciliation
  • Medical review of signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly communication reports/provision of compliance metrics
  • PV Quality Management System Oversight