Get Ready for ICH E6(R3): How to Prepare When You’re Still Struggling to Adopt ICH E6(R2)
Sponsored by The Avoca Group
Tuesday, May 5, 2020 · 11:00 a.m. - 12:00 p.m. EDT
Location: Your office or conference room (no need to travel!)
“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.”
—The Final Concept Paper for ICH E6(R3), dated 17 November 2019
The new guideline will be developed in two waves. The first will focus on ICH E6(R2)’s perceived gaps in an overarching principles and objectives document and Annex 1. The second will focus on designs such as pragmatic clinical trials and decentralized clinical trials, as well as trials that incorporate real-world data sources.
In this webinar, Crissy MacDonald, Avoca vice president, client delivery, and Steve Whittaker, an Avoca senior consultant, will share the benefits of proactive preparation regarding both waves.
They’ll explain how to take advantage of collaboration opportunities within innovation alliances such as technology and turn capabilities into a diversifying set of options for decentralized and virtual trials. All of this is must-know information to evolve your clinical trials.
- Potential revisions to ICH E6(R2) as ICH E6(R3) is authored
- 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
ICH E6(R3) will focus on correcting its predecessor’s gaps and moving GCPs into the future — whether or not you’re ready. Prepare now with this free webinar. Join us by registering today.
Who Will Benefit
Vice presidents, executive directors, directors and managers in:
- 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, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
Meet Your PresenterS
Vice President and Client Delivery
The Avoca Group
Crissy MacDonald is The Avoca Group’s vice president, client delivery, where she leads Avoca’s integrated consulting solutions and oversees the Avoca Quality Consortium® workstreams. Ms. MacDonald provides consulting services to top pharmaceutical, biotech and contract research organizations (CROs), and oversees client deliverables, systems and processes across The Avoca Group. She 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.
The Avoca Group
Steve Whittaker is a senior consultant for 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. Mr. Whittaker’s 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.