Emma Samukange
Kigali
Summary
Pharmacist with extensive work experience in medical products safety, medicine regulation, regulatory systems strengthening and a holder of MSc in Pharmacovigilance and Pharmacoepidemiology. Excellent knowledge in cGMP and Pharmacovigilance regulations and guidelines (WHO, US FDA, ICH, EMA). Good knowledge and experience on the operational procedures of EPI and partners . Mentor and trainer for inspectors for good practices. Aiming to leverage my abilities in the area of Pharmacovigilance.
Overview
19
19
years of professional experience
Work History
Technical assessor and project coordinator
Pharmplay for UNFPA
05.2024 - Current
- Assessing pharmaceutical dossiers for essential medicines submitted to UNFPA
- Coordinating the team of assessors and responsible for the quality assurance of assessment reports.
Technical Assessor and Project Coordinator
Pharmplay for UNFPA
09.2023 - 10.2023
- Assessed 30 pharmaceutical dossiers for essential medicines for UNFPA, coordinated assessors, ensured report quality, and delivered high-quality work within timelines. UNFPA engaged our services again due to impressive quality.
Short Term Consultant
World Bank
05.2021 - 08.2021
- Developed functional model for the following regulatory functions: licensing of establishments, regulatory inspections, and market surveillance in the Kingdom of Eswatini
- Reviewed the available legislative provisions, and other existing guidelines to identify gaps and make recommendations
- Adaptation and adoption of WHO guidelines to develop these regulatory systems tailored to the Eswatini context
- Used the WHO Global Benchmarking Tool to identify gaps
- Conducted training as part of ensuring effective implementation of the agreed systems
- Presented the work done to the minister of health and advocated for the establishment of a national regulatory authority
- Key achievements: Identified gaps in the different regulatory functions and developed an institutional development plan for the identified gaps
- Developed guidance for requirements of different establishments, dispensing practices, import and export control, regulatory inspection, and product recall
- Created processes for the following: licensing of persons and establishments, establishment of expert committees, import and export control, handling product defects reports, handling of substandard and falsified medical products, and inspection processes
- Developed the corresponding processes required including tools such as forms, checklists, process flow charts
- Developed a road map for the implementation of the developed processes
- Trained 20 participants responsible for the initial implementation of the different regulatory functions.
Technical Assessor
Pharmaplay for UNFPA
11.2017 - 12.2017
- Assessment of pharmaceutical dossiers for essential medicines submitted to UNFPA
- Analysis of data submitted in pharmaceutical dossiers to determine the compliance with standards and requirements of UNFPA for approval of use of the medicines
- Assessed 30 dossiers within the desired timeframe.
Chief Regulatory Officer
The Medicines Control Authority of Zimbabwe
07.2013 - 03.2017
- Coordination and supervision of surveillance activities for medical products including vaccines
- Coordination and supervision of all regulatory inspections for good practices
- Coordination of investigations into product-quality complaints, abuse and misuse of medicines, medication errors
- The country focal person on Substandard and Falsified medical products and liaison with law enforcement, customs and partners to the ministry of health on matters pertaining to import of medicines and quality of medicines on the market
- Coordinator of the Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) inspections conducted as part of the SADC Regional Collaborative Registration Procedure for medicines (Zazibona)
- Member of the Advisory Committee to the Minister of Health on rational medicines use
- This committee was also responsible for the development of all Essential Medicines Lists and Standard Treatment guidelines
- Training and conducting Good Distribution and Storage Practices (GDP/GSP) and GMP inspections of medicines and vaccines
- Training and mentoring GMP inspectors in the SADC national regulatory agencies
- Involved in the WHO Prequalification inspections for Good Manufacturing Practices
- Monitoring and coordination of review of procedures, policies, guidelines and work instructions for inspections, import and export control, and market surveillance activities; to ensure they are well documented and up-to-date
- Benchmarking and evaluation of the Regulatory Inspection, Market Surveillance and control and Licensing Establishments functions using the WHO Global Benchmarking Tool (WHO GBT).
Senior Regulatory Officer
The Medicines Control Authority of Zimbabwe
07.2007 - 06.2013
- Coordinating the Cohort Event Monitoring of Coartemether and involved in causality assessment of individual case safety reports
- Leading in carrying out investigations into product quality issues including product recalls, product defects
- Member of the advisory committee to the Minister of Health on rational medicines use
- This committee was also responsible for the development of all Essential Medicines Lists and Standard Treatment guidelines
- Preparation and review of agendas and minutes for expert committees including the Pharmacovigilance Committee
- Coordinator of training of law enforcement agents, port officials and public prosecutors on laws pertaining to medicines
- The organisation’s representative for communication with the Ministry of Health, donor agencies, civil society and the public.
Regulatory officer
The Medicines Control Authority of Zimbabwe
09.2005 - 06.2007
- Assessor of medicine product dossiers submitted for marketing authorisation
- Inspection of premises and persons involved in medicines for Good Distribution/Storage Practices and Good Manufacturing Practices
- Preparation of agendas and minute taking of Committee meetings.
Preregistration Pharmacist
The Medicines Control Authority of Zimbabwe
03.2005 - 08.2005
Education
Master of Science Pharmacovigilance and Pharmacoepidemiology -
UNIVERSITY OF BORDEAUX- EU2P
Bordeaux, France09.2022
Bachelor of Pharmacy (Honors) -
COLLEGE OF HEALTH SCIENCES, UNIVERSITY OF ZIMBABWE
08.2004
Skills
- Good knowledge of Global requirements for Good Practices
- Level-headed especially under pressure
- Sound understanding of quality management systems such as ISO 9000 series, 17025, 17020
- Proficient in using Microsoft Office Suite
- Self-motivated and organized
- Good at building and maintaining partnerships with different stakeholders
- Good Communicator
- Proficient at developing and delivering training
Personal Information
- Title: Pharmacovigilance Specialist
- Nationality: Zimbabwean
Affiliations
- United States International Visitor Leadership Program (IVLP)
- International Society of Pharmacovigilance (ISOP)
Languages
Shona
Native language
English
Proficient
C2
German
Beginner
A1
Timeline
Technical assessor and project coordinator
Pharmplay for UNFPA
05.2024 - Current
Technical Assessor and Project Coordinator
Pharmplay for UNFPA
09.2023 - 10.2023
Short Term Consultant
World Bank
05.2021 - 08.2021
Technical Assessor
Pharmaplay for UNFPA
11.2017 - 12.2017
Chief Regulatory Officer
The Medicines Control Authority of Zimbabwe
07.2013 - 03.2017
Senior Regulatory Officer
The Medicines Control Authority of Zimbabwe
07.2007 - 06.2013
Regulatory officer
The Medicines Control Authority of Zimbabwe
09.2005 - 06.2007
Preregistration Pharmacist
The Medicines Control Authority of Zimbabwe
03.2005 - 08.2005
Master of Science Pharmacovigilance and Pharmacoepidemiology -
UNIVERSITY OF BORDEAUX- EU2P
Bachelor of Pharmacy (Honors) -
COLLEGE OF HEALTH SCIENCES, UNIVERSITY OF ZIMBABWE
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