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News & Events Category: Webinars

AQC Vendor Days

September 7-8, 2022  |  10:00am – 3:00pm EDT
WCG Avoca is excited to offer our first-ever virtual Vendor Days event, during which AQC Vendor Members will showcase their solutions and engage in a group setting where insights and needs will be shared among attendees.

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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: Do You Have an Effective Oversight Plan of Your CRO-Vendor? How Are You Measuring It? ICH E6 R2 Requirements for Vendor Oversight

January 29, 2020 | 11:00am – 12:00pm EST
Sponsor Responsibilities for Quality Management (Section 5.0 of ICH E6 (R2)) requires that Sponsors oversee trial-related duties and functions, including those that are subcontracted by CROs (5.2.2). Quality assurance has changed from assurance of conformity to the assurance that process performance and quality are managed over […]

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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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Webinar: Mock Inspections: A Critical Tool To Ensure Inspection Readiness

July 18, 2019 | 11:00am – 12:00pm EDT
Periodic screenings are an important part of inspection readiness. In this presentation, we’ll discuss the benefits of an ongoing state of inspection readiness throughout a trial, where hidden challenges lurk in an inspection, and how mock inspections can bring these issues to light.

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AQC Member-only Webinar

March 21, 2018 | 11:00am - 12:00pm EDT
Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

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Webinar: QMS and Inspection Readiness

Reviewing The Components Of Quality Management Systems And How They Affect Inspection Readiness Especially In The Context Of The New ICH E6 R2 Requirements Thursday, July 6, 2017  |  10:00 am EDT  |  1 hour   Click here to access the webinar recording and slides, and receive the AQC Leading Practice Quality Agreement   The […]

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Webinar:  Best Practices for CRO Oversight

How an Oversight Capability Maturity Model and Automation Drive Speed and Quality of Clinical Trials Wednesday, June 28, 2017  |  1:00 pm EDT  |  1 hour   Click here to access the webinar slides and receive the AQC OCMM Model Summary   Please join Avoca and Comprehend for or an in-depth look at challenges and […]

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