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 ...

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 ...

Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...

The mission of the International Council for Harmonisation of Technical needs for prescription drugs for Human Use (ICH) is to make sure safe, effective, and high-quality medicines area units are ...

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 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 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 ...

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved. The International Council for Harmonisation’s (ICH) Q9 Quality ...

The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The ...