Dr. Andrea Julsing Keyter
Dr. Andrea Julsing Keyter Has Over 15 Years Of Experience Within The Field Of Regulatory Affairs For Pharmaceuticals And Medical Devices, Regulatory System Strengthening, Quality Management And Production.
She Is A Pharmacist By Profession And Has Completed Her Phd In Regulatory Affairs At The University Of Hertfordshire In The UK In 2020.
She Worked For The South African Health Products Regulatory Authority As A GMP Inspector Followed By Her Role As The Head Of The Medical Device Unit. Prior To That She Worked In The Pharmaceutical Industry Both In Production And Quality Assurance. Dr Keyter Has Expert Knowledge And Experience In Regulatory System Strengthening And The Application Of Reliance Pathways For Enhanced Regulatory Performance.
She Has Participated As A Member And Chair Of A Number Of Committees Including PIC/S, The African Medicines Regulatory Harmonization And The African Medical Device Forum; And WHO-Led Working Groups Relating To Quality Management Systems For National Regulatory Authorities, HIV Self-Testing, Artificial Intelligence For Health, GBT For Medical Devices And Post-Market Surveillance.
In Her Current Capacity As A Technical Officer, Appointed In The WHO Regulatory System Strengthening Team, Dr Keyter Is Responsible For WHO-Led Benchmarking Activities, Providing Technical Assistance And Training To Member States And Is The Focal Point For The WHO Coalition Of Interest Parties (CIP) Network And The WHO Global Competency Framework.