Joey Gouws
Biography
Joey Gouws, has retired from the World Health Organization on 31 January 2023 following a career in medicine regulations since 1993.
Until 31 January 2023, Joey Gouws headed, as Team Lead, the Inspection Team of the World Health Organization (WHO) Prequalification Unit based in Geneva, Switzerland where she was responsible for the oversight of all inspections of manufacturing sites relating to medicines, vaccines, medical devices and vector control products including quality control laboratories and clinical trial sites. In addition, she assisted the WHO Regulatory Strengthening System (RSS) Unit with benchmarking and assessment of National Medicine Regulatory Authorities that endeavored to be listed as reached a level of regulatory maturity in terms of the WHO Benchmarking programme.
Until December 2017 Joey headed the National Medicines Regulatory Authority of South Africa, the ‘‘Medicines Control Council (MCC)’’ as Registrar of Medicines appointed by the Minister of Health, South Africa overseeing the registration of medicines and medical devices, importation of medicines for compassionate use, reporting of adverse drug reactions to the WHO Upsala office, facilitated amendments of national legislation and presenting to Parliament, and represented the MCC at various regulatory technical committees in the SADC region. During this period she was appointed to the South African Pharmacy Council as council member representing the Department of Health.
She joined the Department of Health (Medicines Inspectorate), South Africa in 1993 until 1999 as a medicine assessor and GMP inspector and in 2002 was appointed as Head of the Medicines Inspectorate within the Department of Health with duties relating to GMP, GWP, QCL and GCP inspections, both domestic and International, the licensing of medicine and device manufacturers and wholesalers and overseeing compliance to the Medicines and Related Substances Act, Act 101 of 1965, which included importation, advertising, pharmacovigilance, illegal and substandard medicines and product complaints.
As a Pharmacist, her working experience includes retail pharmacy, hospital pharmacy and managing the Regulatory Affairs Department of the pharmaceutical company Bayer (PTY) LTD, Johannesburg.
Joey holds both a Science degree (BSc) and a Pharmacy degree (BPharm) from the University of North West, Potchefstroom, a Honnors degree in Pharmacology (B Pharm Honns), a Pharmacy Master’s degree in Pharmacology (MPharm) and a Doctorate in Pharmaceutics (PhD) as well as a MBA from the Gibbs Business School, University of Pretoria, South Africa.
Joey is a member of a number of International Pharmaceutical Associations i.e. ISPE, and served as Chairperson of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), Geneva for the period 2014-2015 and served as PIC/S Executive Bureau Member during the period 2009-2017