Relative risk and risk assessment has played a central role in the covid-19 vaccine development and rollout. The issue of the very rare risk of blood clots posed by the vaccine set against the much more serious issue of blood clots from the disease itself (10-times greater), as well as hospitalisation and death posed by the virus. What has become very clear is that risk is often viewed quite differently by experts with the Danish agency completely banning the AZ vaccine, the French agency initially banning it for the elderly before banning it for those under 55 and, in the UK, the MHRA advising the use of alternative vaccines for those under 40.
Too often risk assessment gets bogged down in which tool should be applied, rather than the more important aspects of how do we quantify the relative risk of different issues.
This mini symposium will look at risk assessment; the opportunities and challenges, through the lens of three topical case studies.
The first presentation will look at the different risks posed by quality issues with a critical medicine; and the risk/benefit, i.e. which risk is more important - the risk of discontinuing the medication versus the potential risk posed to the patient by the quality issues.
The second presentation will look at the very real risk of worker safety posed by residual azide in the valsartan process versus the potential risk of formation of nitrosamine by-products and an overview of how the EMA wants to modify ICH Q9 viewed through the lens of the "failures to accurately predict the nitrosamine risk".
The final presentation will focus on the risks associated with analytical QbD; looking at which tools might be helpful for the analytical chemist both in a development and commercial setting, and some suggestions of how the different assessments and tools might link together.
Speakers:
Dr David Elder - JPAG/Consultant
Derek Lonergan - Jazz Pharmaceuticals
Steven Mount - AstraZeneca
EVENT LINK: https://www.jpag.org/160
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