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

Recorded Tuesday, May 5, 2020 | 11:00am – 12:00pm EDT

This webinar discussed the benefits of proactive preparation for ICH E6(R3) with an emphasis on collaboration opportunities within innovation alliances, such as technology and capabilities into a diversifying set of options for decentralized and virtual trials.

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.”

Learning Objectives:

Gain an early understanding of the potential revisions to ICH E6(R2) as ICH E6(R3) is authored.
Understand the possibilities for the use of technology, real-world data, and other variables, as regulators and the industry transition to decentralized, virtual, and other approaches for the conduct of clinical trials.
Synergistic opportunities for how the pharma/biotech industry may collaborate with regulators, service providers, healthcare providers, technology companies, and patients to rapidly and effectively capitalize on the new regulations and advance the potential benefits of diverse approaches to clinical trials.

Presenters:

Crissy MacDonald

Vice President, Client Delivery

The Avoca Group

As the leader of The Avoca Group’s integrated consulting solutions and overseer of the Avoca Quality Consortium^® workstreams, Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group. Crissy has over 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development.

Steve Whittaker

Senior Consultant

The Avoca Group

Steve Whittaker is a Senior Consultant with The Avoca Group and former Executive Director of the Avoca Quality Consortium^®. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies, and execution plans. His experience through years of drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.

This Webinar is Ideally Suited For:

VPs, Executive Directors, Directors, and Managers in the following roles:

Clinical Development
Clinical Documentation Management
Clinical Operations
Clinical Project Management
Clinical Quality Assurance
Clinical Quality Compliance
Clinical Quality Management
Clinical Research
Clinical Trial Management
Company Executives
Data Management
Internal/External Auditing
Process Optimization
Regulatory Affairs/Global Regulatory Affairs
Safety and Risk Management Operations
Technology and Innovation
Training, GCP, GVP

And the following types of organizations:

Pharmaceutical-Clinical Research Groups
Biotech Companies
Clinical Research Organizations (CRO)
Clinical Research Sponsor Companies

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