MRS PORTIA NKAMBULE
Pretoria
Overview
27
27
years of professional experience
Work History
Chief Regulatory Officer
South African Health Products Regulatory Authority, SAHPRA
07.2019 - 09.2024
- Assist the Chief Executive Officer with the formulation and implementation of the SAHPRA Strategic and Annual Performance Plans
- Provide strategic technical and operational direction and ensure implementation and coordination of the various functions related to the regulation of medicines and medical devices
- Advise the Chief Executive Officer and management team on key technical and operational matters and make recommendations on the overall regulatory strategy of the Authority
- Ensure that the Authority’s core/regulatory functions are managed and implemented in line with applicable policies and procedures as set out by relevant legislation and regulations including the Medicines and Related Substances Act 101 of 1965 and its Regulations as amended
- Participate in the revision of Medicines and Related Substances Act 101 of 1965 and its Regulations, Human and Veterinary medicines and Medical Devices
- Development and implementation of the Reliance framework for SAHPRA for all regulatory functions for medicines including vaccines and medical devices and diagnostics to ensure timeous access to safe, efficacious and quality medical products
- Development and implementation of the Good Regulatory Practices guideline for SAHPRA for all regulatory functions for medicines
- Participate in SADC Medicines Regulatory harmonisation, African Medicines Regulatory Harmonisation initiatives and other international harmonisation initiatives to ensure harmonisation of regulatory functions and requirements
- Provide support services to the Authority, Board, Board committees, Expert committees, Programmes/Departments, units/divisions and staff
- Mentor and manage senior managers, to ensure they have the skills required by the organisation and are able to achieve their performance objectives
- Assume direct responsibility for the performance management of senior managers and regulatory business units
- Provide guidance, leadership and management of SAHPRA’s performance metrics and measurement reporting processes
- Provide regular reports to the Chief Executive Officer and Board of SAHPRA on the functioning and regulatory performance of the Authority and chair the Registration and Policy development committee
- Perform on-going review of SAHPRA’s technical and operational strategy in line with international regulatory best practices
- Ensure that SAHPRA’s activities comply with organisational requirements for quality management, legal stipulations, and general duty of care
- Oversee the application of sound corporate governance and risk management processes to protect the interests of the Authority and the public and ensure compliance with all statutory requirements
- Ensure effective public relations management with external and internal stakeholders and the promotion of a positive organisational image
- Liaise with the Ministry and Department of Health, other government departments and entities (e.g
- Agriculture, Forestry and Fisheries, Trade and Industry, Science and Technology, Environmental Affairs, etc.), SADC and other countries, industry bodies as well as relevant international regulatory authorities and bodies that are necessary to achieve the objectives of the Authority
- Lead the authority in the attainment of the RCORE for vaccine regulatory oversight
- Review fees Regulations
- Ensure efficient execution of regulatory functions through a robust end-end process
- Development and implementation of the National Vigilance framework
- Develop, revise and implement regulatory policies and guidelines for human and veterinary medicines clinical trials, package inserts/professional information/SMPC and patient information leaflets, inspections (Good Manufacturing Practices, Good Distribution Practices, Good Clinical Practices, Good Wholesaling Practices and Good Vigilance Practice, licensing, regulatory enforcement/compliance, post marketing surveillance, laboratory testing for medicines, registration/market authorisation, lot release of vaccines, vigilance, internal guidelines for evaluations
- Facilitated communication between programmes/departments, fostering a culture of regulatory awareness and commitment to best practices.
- Developed strong working relationships with other regulators, enhancing trust and cooperation in addressing regulatory matters.
- Reviewed Memorandum of Understanding/Agreements with other regulators and institutions
- Leveraged strong analytical skills to assess complex situations, identifying potential risks and proposing solutions for mitigation.
- Analyzed legislation, identifying key impacts on organizational practices and taking necessary steps to ensure compliance.
- Ensured timely preparation of required reports by coordinating efforts across multiple departments within the organization.
- Demonstrated leadership in driving initiatives aimed at reducing organizational risk exposure while adhering strictly to regulatory requirements.
- Performed and documented quality control checks to maintain compliance with the authority initiatives.
- Managed and responded to industry queries.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Managed revenue recognition and applications and tracked applications progress
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Kept abreast of evolving regulatory trends, allowing the authority to adapt quickly to changes in the regulatory landscape.
- Provided expert guidance during the development of new products, ensuring adherence to relevant regulations.
- Evaluated existing policies against current regulations, identifying gaps or areas requiring improvement
- Provided expert guidance on global regulations
- Provided exceptional support during audits by the Internal audit and the Auditor General showcasing the authority's commitment to regulatory excellence.
- Championed a culture of continuous improvement, regularly reviewing processes and procedures for opportunities to enhance efficiency and effectiveness.
- Streamlined reporting processes for improved efficiency in meeting deadlines and maintaining accuracy.
- Served as an authoritative resource on all regulatory matters, providing clear guidance to stakeholders at all levels within the organization.
- Skilled at working independently and collaboratively in a team environment.
- Actively participated in conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Acting Chief Executive Officer
South African Health Products Regulatory Authority
02.2018 - 12.2019
- Regulatory Authority (SAHPRA) formerly known as Medicines Control Council, Strategic leadership: Provide appropriate strategic guidance to ensure that the Medicines and Related Substances Act is effectively implemented, and that all reasonable actions are taken to effect compliance with this Act and all other legislative prescripts
- Oversee the implementation of the SAHPRA strategic framework in a manner that meets the requirements of all key stakeholders
- Provide strategic direction and oversee implementation of various functions related to the regulation of medicines and medical devices
- Ensure that the Authority’s core functions are implemented in line with applicable protocols and policies as set out by relevant legislation and regulations
- Provide regular reports to the board of SAHPRA on the functioning and performance of the Authority
- Financial management: Ensure that the Authority complies with prevailing legislative requirements regarding the management and utilization of funds and other resources and that all activities of a financial nature are conducted with probity and in line with the PFMA
- Executive Management: Lead the general management of the Authority and carry out all functions assigned to the Authority by the Board and the enabling legislation
- Lead the executive management team of SAHPRA responsible for strategic planning and management of the organisation
- Oversee the application of sound corporate governance and risk management processes to protect the interests of the Authority and the public and to ensure compliance with all statutory requirements
- Liaise with the Ministry and Department of Health; other government Departments and Entities (e.g
- Agriculture, Forestry and Fisheries, Trade and Industry, Science and Technology, Environmental Affairs, etc.); SADC and other countries, industry bodies as well as relevant international regulatory authorities and bodies that are necessary to achieve the objectives of the Authority
- Participate in SADC Medicines Regulatory harmonisation and African Medicines Regulatory Harmonisation initiatives and other international harmonisation initiatives to ensure harmonisation of regulatory functions and requirements
- Mentor and manage managers, to ensure they have the skills required by the organisation and are able to achieve their performance objectives,
- Reviewed individual department performance and worked with leadership to improve processes, procedures, and practices.
- Improved operational efficiency by redesigning internal processes and implementing cutting-edge solutions.
- Implemented comprehensive risk management strategies to mitigate potential threats and safeguard the regulator's assets and interests.
- Managed time efficiently in order to complete all tasks within deadlines.
Director
Medicines Control Council, Ministry of Health
12.2012 - 07.2019
- Evaluation of clinical trial applications, bioequivalence protocols and assist with minor protocol amendments including vaccine applications, registration dossiers
- Compiling reports on special approvals (use of unregistered medicines), clinical trials, and clinical evaluations including pharmacovigilance
- Participate in SADC Medicines Regulatory Harmonisation and African Medicines Regulatory Harmonisation initiatives and other international harmonisation initiatives to ensure harmonisation of regulatory functions and requirements
- Participate in the revision of Medicines and Related Substances Act 101 of 1965 and its Regulations and the stakeholder consultation process and review of comments received from stakeholders
- Chair the Registration and policy development committee
- Managing, record and monitor review timelines for clinical trial applications and special approvals of unregistered medicines
- Prepare monthly stats on clinical trials
- Screening of new clinical trial applications
- Train new staff members
- Management and oversee Section 21-unit, Clinical trials unit, Clinical Evaluations unit and Pharmacovigilance unit
- Supervise preparation of Clinical committee, clinical trials and Pharmacovigilance committee documents
- Supervise preparation of MCC documents and Minutes from Clinical Evaluations and Trials directorate for registration purpose
- Assist in the formulation and implementation of the Cluster’s Strategic, Annual Performance Plans and develop Annual Operational Plans for the Directorate
- Prepare quarterly and annual reports for work done in the directorate
- Compile budget reports for the directorate
- Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
- Financial, human resource and performance management of the staff in the directorate
- Follow up with the external reviewers on work allocated to them
- Compile stats on work done in the directorate
- Quarterly assessment of performance of Deputy Directors and clinical trials unit staff in the directorate
- Answering of Parliamentary questions and attending to any legal matters
- Perform any duty as delegated by the Cluster Manager
- Supervise allocation and evaluation of generic applications and follow up on evaluation of New Chemical Entities including Package insert amendments
- Advise members of industry on administrative and technical issues
- Participate in the development of Complementary Medicines Regulations and guidelines, Clinical guidelines, Clinical Trials guidelines,
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
- Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
- Trained and guided team members to maintain high productivity and performance metrics.
Deputy Director
Medicines Control Council, Ministry of Health
01.2006 - 11.2012
- Manage the clinical trials unit and all clinical trials related activities
- Supervise, guide and train technical and administrative staff in the clinical trials unit
- Participate in SADC Medicines Regulatory harmonisation and African Medicines Regulatory Harmonisation initiatives and other international harmonisation initiatives to ensure harmonisation of regulatory functions and requirements
- Participate in the revision of Medicines and Related Substances Act 101 of 1965 and its Regulations and the stakeholder consultation process and review of comments received from stakeholders
- Manage staffing arrangements in the clinical trials unit
- Management of the clinical trial database
- Assist with the budget for the directorate
- Assist with compilation of budget reports for the directorate
- Screening of new clinical trial applications
- Evaluation of new clinical trials applications including extension studies, in with the SA GCP guidelines, ICH and WHO guidelines
- Evaluation of minor protocol amendments
- Evaluation of progress reports and responses from applicants
- Evaluation of post marketing clinical trials (notification studies)
- Generating reports and presenting to the committee and MCC
- Development of clinical trial policy documents, guidelines and Standard Operations Plans (SOPs) and facilitate implementation
- Allocation of clinical trials applications to clinical trials evaluators
- Liaising with external evaluators on any clinical trial matters
- Oversee clinical trial committee meeting arrangements
- Answering of parliamentary questions regarding clinical trials during office and after hours Oversee the capturing of clinical trials committee recommendations and Medicines Control Council resolutions in the meetings
- Train technical and administrative staff in the Clinical Evaluation unit
- Participate in the evaluation of safety and efficacy of medicines for registration purposes and amendments of package inserts
- Deputise the Director and support any other function the Director requires
- Liaising and visiting other Medicines Regulatory authorities ( e.g TGA in Australia, FDA in USA etc) National Department of Health
- Increased overall efficiency by identifying areas of improvement and implementing necessary changes.
- Oversaw project management efforts, ensuring timely completion of projects within allocated budgets and scope.
- Collaborated with other department heads to ensure smooth functioning of organizational activities.
Chief Medicines Control Officer
Medicines Control Council, Ministry of Health
01.2002 - 01.2006
- Managing and supervising technical and administrative staff in the clinical Evaluations unit
- Manage staffing arrangement in the clinical evaluations’ unit
- Acted as the Director of Clinical Evaluations and Trials Directorate on several occasions
- Evaluation of medicine applications for safety, efficacy and quality including package inserts amendments and fast tracks
- Monitor the updating and maintenance of databases in the clinical evaluations unit
- Compile submissions to senior management including the Minister
- Screening of new generic applications (including generics with clinical data), new chemical entities and correspondences intended for the clinical unit
- Allocation of new chemical entities and clinical submissions to evaluators and clinical committee members according to their areas of expertise
- Preparation of the clinical committee meetings agenda
- Preparation of reports for the clinical committee and presentation of reports at the clinical committee meetings
- Evaluation of bioequivalence studies (clinical trials) to ensure that the guidelines set out in the Declaration of Helsinki, ICH guidelines for Good Clinical Practice and South African guidelines for Good Clinical Practice in the conduct of Clinical Trials are followed, preparation of reports and presentation of reports at the meeting
- Preparing documents for Medicines Control Council and clinical committee
- Attending the clinical committee and Medicines Control Council meetings and capturing of clinical committee recommendations and Council resolutions on registration, post registration and registrability matters
- Communication of the clinical committee recommendations and Council resolutions to the applicants (pharmaceutical companies)
- Development of Clinical committee meeting schedules, timelines and monitoring of clinical committee’s activities and workflow
- Establishing a priority review fast track for medicine applications in accordance with Act 101 of 1965 as amended
- Liaising with external evaluators, committee members and the chairperson of the clinical committee on any clinical evaluation matters
- Taking minutes of Council resolutions on registration matters and compiling a minutes document
- Taking minutes of the recommendations of the Central Clinical Committee and preparing a minutes document
- Evaluation and development of generic package insert templates (standardized package inserts)
- Co-ordinate referrals of expert committees of Council
- Managing responses from applicants
- Interviews members from industry to explain Central Clinical Committee/Council decisions and give advice when so required
- Attending to queries and complaints addressed to the clinical unit
- Quarterly assessment of performance of technical and administrative staff members of the Clinical Evaluations unit
- General budgeting and human resource management (creation and filling of posts in the clinical evaluations unit)
- Identifying the needs (resources and materials) required for the smooth and effective running of the clinical evaluations’ unit
- Answering of Parliamentary questions on any clinical evaluation matter
- Co-ordinating all activities of the clinical unit and the clinical committee
- Development of policy documents, guidelines and Standard Operations Plans (SOPs) and facilitate implementation
- Assist with budgeting and financial management for the unit
- Participated in finalization of Regulations of the Medicines and Related Substances Control Act 101 of 1965 as amended,
- Reduced operational risks through proactive identification and mitigation of potential issues.
- Managed a team of junior control officers, providing guidance and mentorship in their professional development.
- Collected, arranged, and input information into database system.
- Managed budgeting process, aligning departmental budgets with organizational goals and monitoring performance against targets.
- Conducted regular reviews of operations and identified areas for improvement.
- Evaluated staff performance and provided coaching to address inefficiencies.
- Maintained database systems to track and analyze operational data.
Principal Medicines Control Officer
Medicines Control Council, Ministry of Health
01.2000 - 01.2002
- Evaluating package inserts and performing regular updates (old process and generics)
- Establishing a priority review fast track for medicine applications in line with the Department of Health policy
- Evaluating proprietary names in accordance with established guidelines
- Liaising with external evaluators on any clinical evaluation matters
- Preparing documents and reports for Clinical committee and Council
- Assisting in taking minutes of Medicines Control Council resolutions on medicine registration matters
- Assisting in taking minutes of the recommendations of the Central Clinical Committee
- Managing responses from applicants
- Attending meetings of the Clinical Committee and its sub-committees
- Interviews members from industry to explain Central Clinical Committee recommendations, other queries and give advice when so required
- Attending registrability working group meetings and providing input
Regional Pharmacist
Gauteng Provincial Department of Health
01.1999 - 01.2000
- Managing the Pharmacy and the Pre-pack unit
- Drug Supply management in all the districts in the East Rand Region
- Training Primary Health care nurses on drug supply management
- Ordering of stock or medicines from the depot (Auckland Park)
- Supervising repacking of medicines from bulk containers into patient ready packets
- Dispensing of psychotropic medicines to clinics, community health care centers, old age homes and districts (municipal and Province clinics)
- Co-ordinating activities in the Pharmacy and the pre-pack unit
- Member of the East Rand Regional pharmacists and Therapeutics committee
- Contact person for E.P.I (Expanded Programme in Immunisation) for East Rand Region
- EDL implementation in clinics, community health care centers, old age homes and districts
- Monitoring of East Rand clinics medicine orders
- Attending to queries addressed to the Pharmacy, IN THE PHARMACY PROFESSION
- Involved in E.P.I
- Review and E.D.L baseline study for Gauteng Department of Health as a data collector
- Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
- Participated in community outreach events, educating the public about proper medication use, storage, and disposal techniques.
- Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
- Assisted other pharmacy staff with drug inventory, purchasing and receiving.
- Effectively prioritized tasks and organized workflow to increase efficiency.
- Supervised and coached team of pharmacy technicians and trainees.
- Maintained up-to-date knowledge on emerging pharmaceutical trends by attending conferences and completing continuing education courses.
- Monitored ordering of pharmacy medication stock to maintain streamlined inventory and low overhead.
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.
- Enhanced pharmacy efficiency by implementing new workflow processes and inventory management systems.
- Mentored and trained new pharmacists and pharmacy technicians, fostering a supportive work environment focused on professional growth.
- Conducted regular audits of the pharmacy''s controlled substances inventory, ensuring accurate record-keeping and preventing diversion or theft.
- Assisted in the development of policies and procedures related to pharmacy operations, promoting compliance with legal regulations and best practices.
Pharmacist Intern
Provincial Department of Health
01.1998 - 01.1999
- In patient dispensing: dispensing medication to wards and maintaining stock levels and assisting with Scheduling 5, 6 and 7 requisitions
- Outpatient dispensing: dispensing of prescriptions to patients visiting the hospital
- Patient counseling and patient care
- Bulk compounding and prepacking: preparation of extemporaneous mixture for specific patient, disinfectants mixtures used in the hospital, repacking of medicines from bulk containers into patient ready packets
- Also involved in Therapeutic drug monitoring, Administering of Total Parenteral Nutrition and oncology medicines at Chris Hani Baragwanath Hospital
- Assisting with EDL implementation in clinics
- Monitored inventory levels and notified pharmacist of items requiring reorder.
- Utilized strong communication skills to educate patients on proper medication usage, potential side effects, and drug interactions.
- Counseled patients on new medications and OTC products.
- Reduced medication errors by diligently verifying prescriptions for accuracy before dispensing to patients.
- Contributed to a positive work environment through effective teamwork and collaboration with pharmacy staff members.
- Developed strong relationships with healthcare providers to facilitate timely prescription refills and authorizations as needed.
- Consistently demonstrated professionalism and dedication to the field of pharmacy by adhering to all applicable laws, regulations, and professional standards during the internship experience.
Education
MASTER OF PUBLIC HEALTH -
University of South Africa in collaboration with University of Kwa-Zulu Natal
Certificate of Attendance of Bioequivalence Training for Regulatory Staff -
University of Pretoria
Good Clinical Practice Basic course -
Abbott Laboratories and Health Science Academy
Evidence based medicine and Pharmacoeconomics -
University of New Castle, Australia
Good Clinical Practice in Clinical Research -
Health Science Academy
Pharmacovigilance -
WHO, Uppsala Monitoring Centre, Sweden
BACHELOR OF PHARMACY -
University of The Witwatersrand
01.1997
Bsc Degree Nursing -
University of The Witwatersrand
01.1992
Matric Exemption (MD) - English, Afrikaans, N Sotho Mathematics, Physical Science and Biology
Marumofase High school
01.1991
Skills
- Legal Research
- Documentation Review
- Compliance Monitoring
- Regulatory reporting
- Regulatory Submissions
- Global Regulatory Compliance
- Regulatory Policies
- Document Management
- Risk Management
- Audits
- Inspections
- International Regulations
- Product Lifecycle Management
- ISO Standards
- Technical Writing
- Product Information
- Report creation
- Cross-functional team leadership
- Regulation compliance
- Regulatory strategy development
- Teamwork and Collaboration
- Problem-Solving
- Time Management
- Attention to Detail
- Leadership skills
- Multitasking
- Problem-solving abilities
- Reliability
- Excellent Communication (written and verbal)
- Critical Thinking
- Organizational Skills
- Relationship Building
- Stakeholder engagement
- Interpersonal Skills
- Analytical Thinking
- Operational planning
- Conflict Resolution
- Training and Development
- Goal Setting
- Strategic Planning
- Quality Assurance
- Project Management
- Process Validation
- Auditing skills
- Analytical Skills
- Policy Development
- SOP Development
- Process Improvement
Affiliations
- The National Health Research Ethics Council – Council appointed by the Minister of Health in line with the National Health Act 61 of 2003. The Council advises the Department of Health on the management of health research ethics matters in South Africa.
- The Ministerial Advisory Committee on Antimicrobial Resistance (AMR) – Committee appointed by the Minister of Health in line with the National Health Act 61 of 2003. The Council advises the Department of Health on matters relating to antimicrobial resistance.
- SADC Heads of agencies regulators forum which provides technical advice and guidance on regulatory issues relating to medicines and health commodities in the SADC region. The Regulators’ Forum acts as the Project Steering Committee for medicines regulatory harmonization activities and supports implementation of regulatory harmonisation initiatives and strengthening of the medicine’s regulatory capacity in the region in-line with the SADC pharmaceutical business plan.
- SADC Zazibona initiative which is a collaboration in medicine registration between national medicines regulatory authorities of all participating countries in the SADC region.
- AMRH – Medicines Policy and Regulatory Reform (MPRR) Technical Committee – whose mandate is to support enhancement of legal and regulatory frameworks for medical products in Africa.
- AMRH – Regulatory Capacity Development (RCD) Technical Committee – whose mandate is to provide technical advice on human resources development needs to strengthen medicines regulatory capacities and systems in Africa. Also, vice chairperson of the vaccine regulatory oversight subcommittee.
- The WHO African Vaccine Regulatory Forum (AVAREF) which aims to strengthen ethics and regulatory capacity for clinical trials ensuring oversight of product development in African countries. Member of the AVAREF Steering Committee representing the SADC region.
- The WHO Developing Countries Vaccine Regulatory Network which aims to support and promote the strengthening of the regulatory oversight during the clinical development of vaccines, authorisation and inspection of clinical trials, evaluation of investigational products, evaluation of registration dossiers and post marketing surveillance in developing countries.
- The African Medicines Regulatory Conference (AMRC) which seeks to position medical products regulation in Africa as a strategic framework for effectively contributing to Post 2015 development agenda and the African Union agenda 2063 by facilitating access to the needed medical products, vaccines and technologies.
- Bi-annual Scientific Conference which reviews progress made with regards to medicines regulatory activities and actions for sustaining the momentum for regulatory systems strengthening and harmonisation in Africa.
- International Council for Harmonisation of Technical Requirements for pharmaceuticals for Human Use (ICH) – which aim to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical products.
- International Medical Devices Regulators Forum – this a voluntary group of medical device regulators which aims to accelerate international medical device regulatory harmonisation and convergence.
Involvementinprofession
Involved in E.P.I. review and E.D.L baseline study for Gauteng Department of Health as a data collector.
Articlescoauthored
- Needs-driven talent and competency development for the next generation of regulatory scientists in Africa, Boitumelo Semete-Makokotlela, Gugu N. Mahlangu, David Mukanga, Delese Mimi Darko, Peter Stonier, Luther Gwaza, Portia Nkambule, Precious Matsoso, Regine Lehnert, Bernd Rosenkranz, Goonaseelan Colin Pillai, 08/03/21, https://doi.org/10.1111/bcp.15020
- Pharmacovigilance: A public health priority for South Africa, Ushma Mehta, Emma Kalk, Andrew Boulle, Portia Nkambule, Joey Gouws, Helen Rees, Karen Cohen, S Afr Health Rev. 2017; 2017: 125–133.
- South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access, Andrea Keyter, Sam Salek, Lorraine Danks, Portia Nkambule, Boitumelo Semete-Makokotlela, Stuart Walker, 34366850, PMC8342884, 10.3389/fphar.2021.699063
- Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward, Tariro Sithole, Gugu Mahlangu, Velma Capote, Tania Sitoie, Saren Shifotoka, Johannes Gaeseb, Lorraine Danks, Portia Nkambule, Alex Juma, Adam Fimbo, Zuma Munkombwe, Bernice Mwale, Sam Salek, Stuart Walker, 34513894, PMC8429484, 10.3389/fmed.2021.742200
- Three ways COVID sped up SA’s medicines approval process and how it can help the National Health Insurance, Bhekisisa Centre for Health journalism – 11/07/22
Surname
Nkambule (Nee Rangata)
Homelanguage
N Sotho & Zulu
Otherlanguages
- English
- Afrikaans
- Tswana
Health
Excellent
Driverslicence
Code 08
Personal Information
- Gender: Female
- Nationality: South African
- Marital Status: Married
References
- Ms Mandisa Hela, Registrar of Medicines, +2782 774 8966
- Dr NE Khomo, Vice Chairperson: Medicine Control Council (MCC) and Clinical Trials committee member, Medicine Control Council/SAHPRA, South Africa, +2782 781 5950
- Prof M Blockman, Department of Internal Medicine, Division of Clinical Pharmacology, Chairperson of Pharmacovigilance Committee, +27834585510
- Prof P Ruff, Division of Medical Oncology, Chairperson Clinical Trials Committee, +27828804546
Participations
- Drafting and reviews of the Medicines and Related Substances Act 101 of 1965 and its regulations as amended several times. Participated in the Parliamentary processes, consulted and presented the revised Act to the National Council of Provinces and other governments structures.
- Regulatory Consultation of the AU Model Law in 2015 in Zimbabwe and also facilitated domestication of the adopted model law in South Africa.
- Revision of the AU Model Law in 2024 and was a member of the drafting team.
- Facilitated at the World Health Organisation GTN/VQ Clinical Trials Authorization training course held in South Africa, participated in the WHO GBT self-benchmarking training.
- WHO GBT assessment of the Tanzanian Medicines and Medical Devices Authority (TMDA), Ethiopian Food and Drug Administration (EFDA), Saudi Food and Drug Authority (SFDA) and Central Drugs Standard Control Organisation (CDSCO) India.
- WHO Performance Evaluation of Health Science Authority (National Drug Regulatory Authority of Singapore) and Ministry of Food and Drug Safety (National Drug Regulatory Authority South Korea) for WHO Listed Authority.
- Served as a panelist, chaired, co-chaired and presented at various conferences and workshops on regulation of medical products.
Timeline
Chief Regulatory Officer
South African Health Products Regulatory Authority, SAHPRA
07.2019 - 09.2024
Acting Chief Executive Officer
South African Health Products Regulatory Authority
02.2018 - 12.2019
Director
Medicines Control Council, Ministry of Health
12.2012 - 07.2019
Deputy Director
Medicines Control Council, Ministry of Health
01.2006 - 11.2012
Chief Medicines Control Officer
Medicines Control Council, Ministry of Health
01.2002 - 01.2006
Principal Medicines Control Officer
Medicines Control Council, Ministry of Health
01.2000 - 01.2002
Regional Pharmacist
Gauteng Provincial Department of Health
01.1999 - 01.2000
Pharmacist Intern
Provincial Department of Health
01.1998 - 01.1999
Good Clinical Practice Basic course -
Abbott Laboratories and Health Science Academy
Good Clinical Practice in Clinical Research -
Health Science Academy
Matric Exemption (MD) - English, Afrikaans, N Sotho Mathematics, Physical Science and Biology
Marumofase High school
MASTER OF PUBLIC HEALTH -
University of South Africa in collaboration with University of Kwa-Zulu Natal
Certificate of Attendance of Bioequivalence Training for Regulatory Staff -
University of Pretoria
Evidence based medicine and Pharmacoeconomics -
University of New Castle, Australia
Pharmacovigilance -
WHO, Uppsala Monitoring Centre, Sweden
BACHELOR OF PHARMACY -
University of The Witwatersrand
Bsc Degree Nursing -
University of The Witwatersrand
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