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News & Events Category: Webinars

Webinar: ICH E6(R3): How to prepare when you’re still struggling to adopt ICH E6(R2)

May 5, 2020  |  11:00am – 12:00pm EDT
The Final Concept Paper for ICH E6(R3), dated 17 November 2019, states, “The action proposed is a full rewrite and reorganization of the ICH E6(R2) Guideline….and will include addressing the application of GCP principles to the increasingly diverse trial types and the data sources being employed to support regulatory and healthcare-related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.”

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Webinar: When Navigating Risk in Clinical Trials, It’s Best to Mind Your CTQs and QTLs

February 18, 2020 | 11:00am – 12:00pm EST
In this webinar, Crissy MacDonald, Executive Director, Client Delivery, The Avoca Group, will discuss the Quality Tolerance Limit requirements of ICH E6 (R2) and the intersect of Section 3 of ICH E8 (R1), where specific focus is given to proactive quality-by-design in clinical trials, including identifying and managing critical-to-quality factors (CTQs).

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Webinar: Will Decentralized Clinical Trials Compound Patient and Data Quality Risks?

October 29, 2019 | 1:00pm – 2:00pm EDT
Decentralized Clinical Trials (DCTs) offer a more patient-centric approach in which fewer clinic visits are required and patient and caregiver burden are reduced. DCTs utilize a wide range of digital technologies to collect safety and efficacy data from study participants, normally remotely from the patient’s own home. […]

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