ICH Consultations Open Until July and August 2022
ISCT Global Regulatory Committees and the Lab Practices Committee will be responding to these ICH Draft Guidances:
ICH Q2(R2) Validation of Analytical Procedures - LINK
Q2(R2) discusses the elements for consideration when validating analytical procedures in registration applications. It provides recommendations on how to derive and evaluate the validation tests for each analytical procedure.
ICH Q14 Analytical Procedure Development - LINK
ICH Q 14 summarizes the science and risk-based approaches for developing and maintaining analytical procedures suitable for the quality assessment of drug substances and drug products.
ICH guideline E11A on pediatric extrapolation - LINK
ICH E 11A describes recommendations for pediatric extrapolation to support the development and authorization of pediatric medicines.
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