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The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management reached Step 4 of the ICH Process in November 2019.
The ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020.
In November 2019, the ICH Assembly met in Singapore for its bi-annual meeting.
In November 2019, the ICH Management Committee met in Singapore for their bi-annual meeting.
The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process.
The ICH M9 Guideline and Q&As on Biopharmaceutics Classification System (BCS)-based biowaivers reached Step 4 of the ICH Process.
The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 4 of the ICH Process.
The International Council for Harmonisation (ICH) met in Singapore from 16 – 20 November 2019, bringing together over 450 participants from ICH’s sixteen Members and thirty-two Observers.