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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 8 Risk Management (ICH Q9) and Subjective Risk Assessments
This podcast episode explores pharmaceutical risk management through ICH Q9 guidelines, focusing on how companies assess and mitigate risks in drug development. The discussion covers key risk assessment tools like Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Special attention is given to the unique challenges of managing risks in botanical pharmaceuticals like psilocybin and cannabis. The episode also examines how Quality by Design (QbD) principles integrate with risk management to create more robust manufacturing processes. It concludes by discussing emerging trends, including the role of AI in risk assessment and the shift toward personalized medicine.
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By Jim Mitchell and Google NotebookLMThis podcast episode explores pharmaceutical risk management through ICH Q9 guidelines, focusing on how companies assess and mitigate risks in drug development. The discussion covers key risk assessment tools like Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Special attention is given to the unique challenges of managing risks in botanical pharmaceuticals like psilocybin and cannabis. The episode also examines how Quality by Design (QbD) principles integrate with risk management to create more robust manufacturing processes. It concludes by discussing emerging trends, including the role of AI in risk assessment and the shift toward personalized medicine.