James Southern PhD: Retired in 2000 – now a part-time consultant, living in Cape Town, South Africa. Born in Cape Town, South Africa 03 March 1945.
Most of my working life has involved the development, manufacture and quality control of vaccines and related materials in the UK and South Africa.
Prior to retirement I was Operations manager for the South African Vaccine Producers, based in Johannesburg. Our products included childhood diptheria-tetanus-whooping cough vaccines, and the African Snake-bite antivenoms.
Since retirement I have been
• a part-time “expert” reviewer for the South African Medicines Regulatory Authority for license of Biological Medicines, and approval of Clinical Trials - mostly vaccines. This is an ongoing commitment.
o I have recently supported the SAHPRA interactions with the African Vaccines Regulatory Forum (AVAREF) in development of harmonized regulatory procedures – particularly related to COVID vaccines and potential MPOX vaccines.
• an expert reviewer for the Dept of Agriculture for safe import and release of genetically modified organisms – mostly human and animal vaccines,
• a Temporary advisor for the World Health Organization;
o drafting guidelines and standards for vaccines and biologicals,
o a Pre-Qualification reviewer of vaccines for purchase by UN Agencies,
o a WHO Training course developer and presenter.
o chair of the Developing Country Vaccine Regulators’ Network 2006 – 2016