TransCelerate is an industry consortium aimed at improving drug development. They have developed a number of tools that improve the conduct of clinical trials. They will be holding a webinar "What You Need to Know about ICH E8 (R1): Using TransCelerate’s Tools to Help Interpret and Implement ICH E8 (R1)” on 2March2023 at 10AM EST. It will be a 1 hour discussion on TransCelerate’s tools and resources for ICH E8 (R1) and its implementation. These solutions target key new concepts in ICH E8 such as Critical to Quality Factors, Stakeholder Engagement, Critical Thinking, and Open Dialogue. The webinar will focus on:
- What’s new in ICH E8 (R1)
- Focus of our work and how our focus topics were chosen
- Overview of the published tools
- Q&A
To register for this free webinar go to this link.
Background on ICH E8 (R1) and Transcelerate.
From the ICH website:
The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.
This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.
From TransCelerate's website:
TransCelerate BioPharma’s mission is to collaborate
across the global biopharmaceutical research and development community
to identify, prioritize, design, and facilitate the implementation of
solutions designed to drive the efficient, effective and high-quality
delivery of new medicines.
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