The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...

Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering. This training is designed for ...

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers. On Oct. 19, 2016, the International Council for Harmonization (ICH) ...

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...

Nigeria’s pharmaceutical regulatory system has recorded a major global breakthrough as the NAFDAC has secured full membership ...

The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier ...

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best ...

The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory ...

The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...