EXECUTIVE MANAGEMENT

B.Semete

Dr Boitumelo Semete-Makokotlela

Chief Executive Officer

Dr Boitumelo Semete-Makokotlela is the CEO of the South African Health Products Regulator. She has a Ph.D. (Biochemistry) and also holds MSc in Management Finance and Investment. She is also a fellow of the African Leadership Initiative. Within the technology innovation space, she managed a biotechnology incubator at The Innovation Hub Management Company. She was with McKinsey & Company for 2 years as a McKinsey Leadership Fellow. Prior to that, she was at the CSIR as a Senior Researcher.

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She completed her postdoctoral research at the University of Nottingham and EPFL, Switzerland. She has published as a first author and co-author in scientific publications, review articles and book chapters. She is also involved a number of thought leadership projects such as the African Union Strategy for Health Research, the East Africa Community Bioeconomy strategy development team and WHO Expert Panel on scaling health Innovations in Africa.

PORTIA-NKAMBULE

Ms Portia Nkambule

Chief Regulatory Officer

Ms Portia Nkambule is a pharmacist with a Masters degree in Public Health. Ms Nkambule studied her B.Pharm degree at the University of Witwatersrand. She received training on Pharmacovigilance at the Uppsala Drug Monitoring Centre in Sweden. She has worked for the Medicines Control Council of South Africa, now the South African Health Products Regulatory Authority (SAHPRA) since 2000. She has extensive experience in medicines registration, variations reviews, clinical trial regulation, bioequivalence protocol reviews, GCP inspections, reviews of unregistered medicines and pharmacovigilance.

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Ms Portia Nkambule participated in the reviews of the Medicines and Related Substances Act 101 of 1965 and its regulations, policies and guidelines development. She was appointed by the then Minister of Health, Dr Aaron Motsoaledi, to represent the medicines regulatory authority in the National Health Research Ethics Council (NHREC). She was nominated by SADC Medicines Regulators to represent SADC at the African Vaccine Regulators Forum (AVAREF). Ms Nkambule participated and chaired regulatory sessions at the International Conference of Drug Regulatory Authorities (ICDRA), Developing Countries Vaccines Regulators Network (DCVRN), African Medicines Regulators Conferences (AMRC), the SADC Medicines Regulators Forum and the SADC Zazibona workshops. She also participated at the World Health Organisation (WHO) global benchmarking of other regulatory authorities using the WHO Global Benchmarking Tool. She acted as the Chief Executive Officer of SAHPRA for 22 months. She currently serves in the role of the Chief Regulatory Officer (CRO) of SAHPRA, responsible for providing executive leadership on medicine registration, variations, clinical trials regulation, law enforcement, inspections, licensing, post marketing surveillance, vigilance, medical device regulation and radiation control.

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Mr. Regardt Gouws

Chief Financial Officer

Mr. Regardt Gouws qualified as a Chartered Accountant [CA(SA)] registered with the South African Institute of Chartered Accountants (SAICA). He has more than 17 years of working experience starting at the AGSA and for the past 10 years as CFO. His previous roles were the CFO at various Public Entities (Freedom Park, Film and Publication Board and the Railway Safety Regulator). His contribution as CFO included five clean audits, the successful implementation of financial systems as well as a financial recovery plan.

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Mr. Gordon Mtakati

Executive Manager: Human Resources

Mr. Gordon Mtakati is the Executive Manager: Human Resources of the South African Health Products Regulatory Authority (SAHPRA).  He holds a Master of Business Administration (MBA) Degree from the then Potchefstroom University, today known as the North West University. In addition, he holds a B. Tech. Degree: Human Resources Management from Technikon South Africa; A National Diploma: Personnel Management from the Vaal Triangle Technikon (Vaal University of Technology); and, a Middle Management Programme Certificate from Henley Business School.

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Registered with the South African Board for People Practices (SABPP) – as a Master Human Resources Professional (MHRP), Generalist.  Mr. Mtakati worked both in Private and Public Sectors, from Piotrans Rea Vaya Joburg; SEBATA Group of Companies; Eskom; International Trade Administration Commission (ITAC) of South Africa, E. Oppenheimer & Son, SBV – Cash-In-Transit; Telkom; USAID/SA – American Embassy Pretoria, Vaal Reefs Gold Mine, and I & J Fisheries in Woodstock, Cape Town. He is currently the Board Chairperson of the Mix FM Radio Station, 93.8 FM (Midrand Community Radio Station).  Previously he was a Board Member of the American Field Services (AFS) Exchange Programmes. Mr. Gordon Mtakati is a Published Author with two books published both in the United Kingdom (UK) and the United States of America (USA).  He is a die-hard supporter of Bafana Bafana,  Kaizer Chiefs and the Blue Bulls.

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Christelna Reynecke

Chief Operations Officer

Ms. Christelna Reynecke is the COO of South African Health Products Regulatory Authority (SAHPRA). She holds Master of Business Administration (MBA) from the Edinburgh Business School (Heriot Watt University). She also has a BPharm Degree from the University of the North West. In addition, she has been endorsed and certified among others for Business Strategy Execution: Designing Agile Operations, Project Management – Prince2 Foundation, Lean Management for All Sectors, Team Leadership & Management Skills 2020 and Import and Exports Trade Logistics.

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With relentless commitment to best practice and an innovative approach to operational improvement, Christelna is passionate about developing and implementing creative solutions that manage business risks, improve operations and secure sustained revenue and reputation. With a key focus on reinforcing corporate fairness, promoting transparency, sustainability and quality, Christelna is a change agent and resourceful and authentic leader.

Over her 21-year career within the healthcare industry she has had the pleasure of working alongside some wonderful colleagues in various roles that she has occupied. From Pharmacist, to Process Manager, Consultant, Responsible Pharmacist, Operations Director and most recently Quality Assurance and Regulatory Director. Most notable projects that she was involved with include SAP systems deployments in the logistics space and a full site construction redevelopment where “acting construction site manager” might have been a more appropriate job title during 2017-2018

Making a positive impact is what she enjoys most. In her personnel time, she is involved with a garden project that enables the OT department at the hospital to use the space for rehabilitation programmes and the garden also provides fresh produce for the hospital kitchen

She enjoys growing things. Plants, trees, people, ideas….

“ We should listen to understand, not listen to respond” – she believes in keeping an open mind and moving forward, random acts of kindness, owning your space, being accountable, “anything worth doing, is worth doing well!”, keeping faith and in December possibly also in Santa Clause.

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Adv Peter Nthotso

Company Secretary

Adv. Peter Nthotso is the Company Secretary of the South African Health Products Regulatory Authority. He holds Bachelor of Laws (LL. B) degree from the University of the Free State and Executive Leadership Certificate from Wits Business School. He has been with various public entities under the Department of Transport fulfilling the roles of Company Secretary and Legal Advisor. He participated in various national Transport structures and worked on legislative reform programmes including digital initiatives supporting law enforcement.