Dr James Southern

Retired in 2000 – now a part-time consultant, living in Cape Town, South Africa. Most of my working life has involved the development, manufacture and quality control of vaccines and related materials in the UK and South Africa. 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.

• an expert reviewer for the Dept of Agriculture for import and release of genetically modified organisms – mostly human and animal vaccines
• and have been a Temporary advisor for the WHO for;
  • drafting guidelines and standards for vaccines and biologicals,
  • Pre-Qualification review of vaccines for purchase by UN Agencies,
  • and Training course development and presentation.

I have recently supported the SAHPRA interactions with AVAREF in development of harmonized regulatory procedures – particularly related to COVID vaccines and potential MPOX vaccines. I am a member of the WHO Expert Committee for Biological Standardization. I was chair of the Developing Country Vaccine Regulators’ Network 2006 until 2016. I was a member of the National Council for Non-proliferation of Weapons of Mass Destruction from 1994 – 2006, and remain an advisor to this council on manufacturing technologies for biotechnology products.