A structured safety system for receiving, documenting, assessing, following up, and appropriately escalating adverse event information associated with our products.
Every safety report contributes to the continuous monitoring of the benefit–risk profile of pharmaceutical products.
EndoCare+ operates pharmacovigilance activities through documented procedures, defined responsibilities, controlled reporting channels, and structured case-handling processes. These processes are designed to support the timely identification, documentation, assessment, follow-up, and appropriate escalation of safety information.
Defined responsibilities and oversight.
Documented procedures supporting consistent pharmacovigilance activities.
Structured channels for receiving adverse event and safety information.
Appropriate follow-up and escalation of cases according to case characteristics and applicable requirements.
Pharmacovigilance activities are supported by documented Standard Operating Procedures (SOPs) that define relevant responsibilities, reporting pathways, case-handling processes, documentation requirements, follow-up activities, and escalation mechanisms.
EndoCare+ conducts pharmacovigilance activities with reference to applicable requirements and guidance issued by the relevant pharmaceutical regulatory authorities in Yemen, including the Supreme Board of Drugs and Medical Appliances (SBDMA). Where applicable, international pharmacovigilance principles and recognized safety-reporting practices are incorporated into our operating framework.
EndoCare+ uses structured adverse-event reporting formats and information requirements designed to capture the essential elements needed for safety assessment and follow-up. Reporting practices are aligned, where applicable, with relevant local regulatory requirements and internationally recognized pharmacovigilance principles.
Safety information may be received through multiple channels, including healthcare professionals, patients, caregivers, customers, distributors, company personnel, regulatory authorities, and other relevant sources. Reports are documented and handled through defined pharmacovigilance processes.
Receiving safety information.
Reviewing the information available for case handling.
Recording relevant case details.
Evaluating the available safety information.
Obtaining additional information where appropriate.
Escalating cases according to seriousness and procedures.
Reports involving serious or potentially serious events receive appropriate attention and escalation according to their characteristics, available information, defined procedures, and applicable regulatory requirements.
Non-serious events and other relevant safety information may also be reported.
Where additional information is necessary and reasonably obtainable, EndoCare+ may conduct follow-up with the reporter or relevant source to clarify case details and support appropriate safety assessment.
Safety information is handled with appropriate confidentiality and access controls. Personal information is used only for legitimate pharmacovigilance, follow-up, regulatory, and related safety purposes, subject to applicable requirements.
Safety intake, case management, follow-up and escalation.
Product quality complaints, quality investigations and relevant interfaces.
Regulatory communication and applicable authority interactions.
Not every product-related report is the same. Suspected adverse events and product quality complaints may require different assessment and handling pathways.
For urgent or serious safety information requiring immediate attention, use the designated pharmacovigilance reporting channel.
“Pharmacovigilance is not limited to a reporting form. It is an ongoing safety culture involving awareness, communication, documentation, follow-up, and continuous attention to the benefit–risk balance of medicines.”
Every safety report helps strengthen the information available to support appropriate decisions and protect patients. EndoCare+ encourages healthcare professionals, patients, caregivers, and other relevant stakeholders to report suspected adverse events and other important safety information.
If you suspect an adverse event related to an EndoCare+ product, please submit a report through our secure channel.
Report a Safety Event