Module 9 2024

03/09/2024

Biotech Regulation

The Organisation for Professionals in Regulatory Affairs

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Two centuries ago

Edward Jenner, 14 th May 1796

• Pustular material from cowpox lesion (Sarah Nelms, a milk maid)

• Inoculated 8 year old boy (James Phipps)

• Boy inoculated with smallpox 6 weeks later

No infection occurred

•

If Jenner’s clinical trial and investigation product had been constrained by a competent authorities and ethical oversight, would vaccines have started here?

The Organisation for Professionals in Regulatory Affairs

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