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News Archive
ICH - Quality Risk Management Q9(R1) Adopted
2nd February 2023Final version adopted on 18th January 2023.
ICH - The ICH M13A draft Guideline presentation available now on the ICH website
2nd February 2023The ICH M13A draft Guideline presentation available now on the ICH website
ICH - Training on Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports
2nd February 2023The ICH Secretariat is pleased to announce the publication of Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video.
ICH - Training on Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Product
2nd February 2023The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022. Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Q13 Expert Working Group.
MHRA - Changes to completed paediatric studies guidance text
2nd February 2023MHRA have made changes made to the Completed paediatric studies guidance text and suggested a new cover letter on their website.
MHRA - Fees Consultation Outcome
2nd February 2023MHRA - Fees Consultation Outcome
MHRA - Innovation Office Guidance
2nd February 2023MHRA Innovation Office: guidance and support - can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
MRC - Motion capture tech could predict disease progression
2nd February 2023MRC - Motion capture tech could predict disease progression
PIC/S - Adoption and Entry into force of New GDP Guidance Documents
2nd February 2023Adoption and Entry into force of New GDP Guidance Documents
WHO - OpenWHO courses
2nd February 2023Three years of pandemic learning response: reaching learners across the world with life-saving health knowledge
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