European hemorrhagic stroke guidelines planned for release in early 2024 are on hold to accommodate newly published data, some of which will alter recommendations.

ICH Q12 guidelines. The Q12 guideline of lifecycle management, although still in draft form, is already turning out to be controversial because it has been issued without the support of industry, ...

The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online May 17 in Stroke.The 80-page document contains major changes and refinements to the 2015 guideline on ...

For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy, which details the key benefit and risk ...

Predictive modelling also helps enable continuous process verification, defined by ICH Q8 as "an alternative approach to process validation in which manufacturing process performance is continuously ...

The International Council for Harmonisation (ICH) earlier this week advanced two guidelines to Step 4, or the implementation period of its process, and one question and answer document on 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 ...

Globally, “AKM is being discussed by multiple stability working groups for integration into international guidelines,” Clénet adds. Insights Biological drug product Biopharmaceuticals ...

Those who have come to believe that "Johnson & Johnson" and "quality" are mutually exclusive terms may be surprised to learn that the healthcare giant's director for quality and compliance ...

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will ...