EXECUTIVE MANAGEMENT

B.Semete

Mrs Boitumelo Semete-Makokotlela

Chief Executive Officer

Mrs 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.

Molatlhegi-Kgauwe

Mr Molatlhegi Kgauwe

Chief Financial Officer

Mr Molatlhegi Kgauwe is a Chief Financial Officer (CFO) of the South African Health Products Regulatory Authority. He holds a B. Com degree and a Post Graduate Diploma in Accounting (CTA equivalent) from the University of Cape Town. He is qualified Chartered Accountant [CA(SA)] registered with the South African Institute of Chartered Accountants (SAICA). He has more than 16 years of working experience which spans both the public and private sectors. His previous roles were the CFO at the Competition Commission of South Africa for three years and nine months and that of the City of Matlosana for two years.

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Prior to that he was a General Manager: Finance at the State Information Technology Agency (SITA) for more than four years. Molatlhegi did his external audit training at PriceWaterhouseCoper (PwC) and thereafter stayed on to become an audit engagement manager before moving on to commerce and industry. Under his leadership, he has managed to improve an organisation from a disclaimer status to a qualified audit outcome and has attained two clean audits.

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.

Peter-Nthotso

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.

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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.