The PMS Department receives:

Samples for retesting from the CAPA or directly from police and MOHP health administrations in case of adverse events relating to the use of a biological product.

AEFI notification from the site of complaint, the CAPA or the EPI.

Complaints relating to the storage of biological products (a.k.a. cold chain complaints) from CAPA, EPI, CDC, governorates, specialized medical centers, health insurance stores or individual users. MOHP health administrations.

 

 

Our Creative Team

Ph/Sherin Hamdy

Department manager

Ph/Olivia Anwar

Technical manager

Ph/Heba Ibrahim

Quality manager

Receives Samples for retesting from the CAPA or directly from police and MOHP health administrations in case of adverse events relating to the use of a biological product.

AEFI notification from the site of complaint, the CAPA or the EPI.

Complaints relating to the storage of biological products (a.k.a. cold chain complaints) from CAPA, EPI, CDC, governorates, specialized medical centers, health insurance stores or individual users. MOHP health administrations.

Internally, the PMS Department also receives PSURs and PBRERs from the Marketing Authorization, Lot Release or Clinical Trials Evaluation Departments. These reports are assessed by the PMS staff members and then their evaluation reports are sent back to the department that initially sent the files for evaluation.

The department also sends the samples received for retesting to the appropriate NCLs then, sends their final report back to the sending agent.

  • PMS: Post-Marketing Surveillance.
  • CAPA: Central Administration of Pharmaceutical Affairs.
  • MOHP: Ministry of Health and Population.
  • AEFI: Adverse Events Following Immunization.
  • EPI: Expanded Program of Immunization.
  • CDC: Center for Disease Control.
  • PSURs: Periodic Safety Update Reports.
  • PBRERs: Periodic Benefit-Risk Evaluation Reports.
  • NCLs: National Control Laboratories.
  • NORCB: National Organization for Research and Control of Biologicals.
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