Elemental Impurity Risk Assessment – Examples – Free PDF Download

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Overview
Using the principles outlined in ICH Q3D and training modules we will:

• Present a series of risk assessments based on actual products.

• Examining different routes of administration.

• Through this seek to highlight there is more than one approach, illustrated through the examples shown.

• Marketing application – example summary and proposed location.

• Approach to products during clinical development.

 

 

Download PDF here

Continue at: https://www.ema.europa.eu/documents/presentation/presentation-elemental-impurity-risk-assessment-case-studies-andrew-teasdale-laura-rutter_en.pdf

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