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Recorded Webinar
Strategic insights into European (CHMP/EMA) and American (FDA) regulatory aspects of stability
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
In the face of risk (likelihood of an unfavorable outcome) and uncertainty (range of possible outcomes), how well do you perform at decision-making? Do you strive to make good decisions or to make the right decisions? If the right decision is the descriptive result of the knowledge of an event that has already occurred, a good decision can be defined as logically consistent, defensible, transparent, and prescriptive. In the face of risk and uncertainty, the webinar addresses why you should strive to make good decisions which may lead to favorable or unfavorable outcomes.
This presentation will cover the following areas :
- Importance of complete characterisation of drug substance and drug product prior to conducting stability.
- Value of stability in establishing proof of comparability.
- Diversity of EU and US, also ICH, written guidances and interpretation.
- Shelf-life and in-use stability.
- Biological, Biological/Product, Biologic/Device, Medicine, Product/Device.
Who should attend
Anyone who is involved in Biological, Biological/Product, Biologic/Device, Medicine, Product/Device.
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