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

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of ...

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH ...

This Q11 guideline describes approaches to developing process and drug substance understanding. It also offers guidance on information that should be included in related common technical documents.

The guideline updates the last AHA/ASA ICH guideline published in 2010 and incorporates the results of new studies published in the interim. The guideline update was purposely delayed for 1 year ...

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 ...

ICH brings together regulatory authorities and pharmaceutical leaders to discuss scientific and technical aspects of medicines and develop ICH guidelines.

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 ...

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques ...

The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering.