Upcoming events

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SAMED-SALDA Regulatory Forum 3 November 2021

3 Nov 2021

In this next forum, we take a look at the Medical Device and In Vitro Diagnostic Regulations in Africa and Europe and how this affects the provision of medical technologies in these areas.

  • CSIR Medtech Regulatory support services and programmes  with CSIR Team, led by Jeremy Wallis

  • African Medical Device Regulations - an update with Lizel Dreyer-Fouche, RA Manager: Africa & Middle East, Abbott Molecular

  • Overview of the European MDR and IVDR with Andre ten Napel, Regulatory Consultant, TNMC Medical Devices

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Ethics, Whistle-blowing and Code developments

10 Nov 2021

In this session, we take a look at good ethics: what it is and why it is important with our Special Guest speaker Paul O'Sullivan, Certified Fraud Examiner, Paul O'Sullivan and Associates; the Whistle-Blowing Hotline: Cases, progress and outcomes with our Ethics Chair Michael Judin, Judin Combrink; how to access and interpret Code Compliance Reports from the MPC platform; compliance Officer declaration & re-certification by the end March 2022 deadline; what the latest developments are on the 18A&B exemptions and recognition of the Code; and, some recent Code Advisory Opinions and what you can learn from them

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