News Archive

ICH - ICH M10 on bioanalytical method validation - Scientific guideline

30th January 2023

ICH M10 on bioanalytical method validation - Scientific guideline

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PharmaTechnica - Free Annex 1 Presentation

30th January 2023

A presentations on Annex 1 presented by GMP Inspector Dr Rainer Gnibl is now available (sign up required).

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ANSM - The implementation of the Clinical Trial Regulation State of play at EU and national level Future initiatives

25th January 2023

ANSM have released their webinar presentation regarding The implementation of the Clinical Trial Regulation State of play at EU and national level - Future initiatives

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023

19th January 2023

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023

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EMA - CTIS newsflash – 13 January 2023

19th January 2023

CTIS newsflash – 13 January 2023

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EMA - Clinical Trials Information System (CTIS) - Sponsor Handbook

19th January 2023

EMA - Clinical Trials Information System (CTIS) - Sponsor Handbook

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EMA - Human Medicines Newsletter, Jan 23

19th January 2023

EMA - Human Medicines Newsletter, January 23

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EMA - SME Newsletter Jan 2023

19th January 2023

EMA - SME Newsletter Jan 2023

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FDA - Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

19th January 2023

FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

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FDA - FDA Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical GMP

19th January 2023

FDA have signed an Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice.

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