The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

What is the ASAP and what you should know about it

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  • The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
  • Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
  • In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
  • This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.

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About this podcast

The podcast from statisticians for statisticians to have a bigger impact at work. This podcast is set up in association with PSI - Promoting Statistical Insight. This podcast helps you to grow your leadership skills, learn about ongoing discussions in the scientific community, build you knowledge about the health sector and be more efficient at work. This podcast helps statisticians at all levels with and without management experience. It is targeted towards the health, but lots of topics will be important for the wider data scientists community.

by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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