Demeke Amare

Significant roles and responsibilities at Pharmacovigilance and PMS Desk are:

• Develop pharmacovigilance directives, guidelines and standard operating procedures
• Develop study protocols for active safety monitoring and post marketing surveillance
• Prepare the final analysis of the active safety studies and PMS, provide recommendations for decision-makers and disseminate the findings to stakeholders through appropriate dissemination platforms.
• Conduct investigation for serious adverse events and prepare comprehensive report for causality assessment, conducted by Pharmacovigilance Advisory Committees(PAC).
• Conduct signal detection, validation and assessment and share the confirmed signals to relevant stakeholders.
• Assessment of submitted PSURs/DSURs/PBRERs/ RMPs documents and prepare reports that need to be communicated with relevant stakeholders.
• Prepare training modules and provide regular trainings for healthcare professionals.

Significant roles and responsibilities at Pharmacovigilance and Clinical Trial Department were:

• Evaluation and Authorization of Clinical Trial applications submitted to the Ethiopian Food and Drug Authority.
• Regular onsite inspections of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) at clinical trial study sites.
• Evaluate the development safety update report (DSUR) and the Suspected Unexpected Serious Adverse Reaction (SUSAR) and communicate the information to the clinical trial stakeholders (e.g., national ethics committee, national clinical trial advisory committee, sponsor and investigator, etc.)
• Evaluate and monitor clinical study progress reports and final reports and provide appropriate feedback.
• Supervision of ethical committees at various levels, as well as communication with them to share information about participant well-being and trial progress.
• Evaluate and present high risk clinical trials to the national clinical trials advisory committee.
• Develop clinical trial standard operating procedures (SOPs), PV newsletters, guidelines, directive and regulation.
• Develop clinical training materials and provide training to staff, trial stakeholders and advocacy work for government agencies.
• Conduct GVP inspection and signal detection, validation and assessment.
• Develop project proposals and coordinate research activities with regard to vaccine and medicine safety studies
• Receive, record and acknowledge adverse events reported by Healthcare professionals, customers and patients.
• Evaluate PSUR/PBRER/RMP and communicate the results to relevant stakeholders.
• Conduct ADR/AEFI investigations and provide pharmacovigilance training to health workers, regional regulators and EPI staffs.

Significant roles and responsibilities at Medicine Evaluation and Market Authorization Department are:

• Dossier evaluation, market authorization and registration of new medicine, generic medicines, biological and bio-similar products.
• Provide technical assistance to local manufacturers regarding the preparation of quality dossiers, proper implementation of current good manufacturing practices (cGMP) and maintenance of quality assurance system throughout the manufacturing facility.
• Evaluate variation applications and further replies of medicine dossiers submitted by market authorization holders (MAHs) and provide regulatory feed-backs.
• Supervise and monitor dossier evaluation activities of junior assessors to be conducted in compliance with citizen charters
• Conduct GMP audit for Foreign Pharmaceuticals Manufacturers as a Lead Inspector.
• Prepare SOPs, registration guidelines (generic medicine, traditional medicine, variation, bio equivalence and low risk) and legal documents such as directives and regulations.
• Provide training for junior dossier assessors, closely monitor and evaluate their technical performances.

Significant roles and responsibilities at Medicine Quality Control Department are:

• Develop post-marketing surveillance project proposals for medicines that are of public importance (anti-TB medications, ARV drugs, anti-malarial drugs, drugs for reproductive use, and etc.)
• Participate in inter-laboratory quality control proficiency testing at the regional and international levels.
• Perform quality control analysis for pre-market and post marked medicines
• Conduct GMP audit for overseas pharmaceutical manufacturers, to ensure their compliance with national and International quality standards.
• Regularly provide capacity building training and support for QC laboratories at local pharmaceutical manufacturers and EFDA regional laboratories.
• Prepare standard operating procedures (SOPs), performance evaluation forms and training materials for QC laboratory.
• Conduct performance verification tests for high-tech analytical instruments, apparatuses and devices on a regular basis.
• Develop validation protocol and conduct analytical method validation/verification for new and generic products testing.
• Perform regular maintenance for QC laboratory instruments, equipments and apparatuses.

Significant roles and responsibilities at Pharmacy Department are:

• Lead, manage, coach and mentor pharmacy staff
• Receive consumption reports from various clinical units and purchase medicines, laboratory reagents, and medical devices from the Ethiopian Pharmaceutical Supply Agency (PFSA).
• Conduct periodic inventory of stock status and monitor the facility's adoption of rational medicine use.
• Actively participate in the improvement of pharmacy information and automation systems to increase medication management efficiency and accuracy.
• Periodically prepare and deliver health center consumption reports to the senior leadership team of the health center as well as provide analysis and recommendations.
• Actively participate in the compilation of Health Center essential drug lists and possible revisions as well as advocating for medical staffs on the use of rational drug uses.
• Serve as secretary of the Akakai Health Center's Drug and Therapeutic Committee (DTC).