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3-4 June

Amsterdam

AGENDA AT-A-GLANCE

Day 1

Innovation Today: What’s happening today, in this moment, to make every team and every person the best they can be in Quality and Compliance.

Day 2

Innovation of the Future: How will clinical trials evolve? As we look to the future, collaboration will be more important than ever.

 

The 2020 Avoca Quality and Innovation Summit will offer hands-on, deep-dive workshops in the areas of:

  • ICH E6 (R2) and Risk Management: With ICH E6 (R2) mandating the implementation of a risk-based approach to all phases of trial execution, clinical development teams must find new approaches to risk management.
  • Inspection Readiness: Key parameters to being proactive and ready for inspection. Participants will share inspection experiences.
  • Lessons Learned: Breaking down silos and creating a pathway to sharing lessons learned across organizations by leveraging collaboration.
  • ICH E8 and Quality-by-Design: What your organization needs to do to ensure compliance with the new ICH E8 guideline as it relates to quality-by-design.

 

Preliminary session themes and topics will include:

  • Current state of the industry as it pertains to patient-centered approaches. How the ICH E8 requirement to utilize patient-centered drug development affects patients and its impact on the clinical trial execution process.
  • Empowering your own individual change. How changing our activities can deliver new results, by Jim Lawless, motivational speaker and author of Taming Tigers.
  • Innovation and technology disruptors. How emerging trends in technologies will impact clinical trials, such as patient safety, data integrity, and traditional operations models.
  • Quality and risk executive panel. How the increasing complexity in study design, amount of data, and patient demands affect quality and risk management.

 

KEYNOTE:

Innovation through Collaboration: Turning Hope into Action: How Staying Positive and Questioning the Status Quo Can Lead to Breakthroughs

Co-founder and executive director of the Castleman Disease Collaborative Network, David Fajgenbaum authored his powerful, life-changing story, Chasing my Cure.

When faced with a life-threatening illness with no known cure, David Fajgenbaum made it his mission to find one. He uses his story to illustrate how questioning the status quo can lead to profound breakthroughs.

Dr. David Fajgenbaum
Author of Chasing My Cure
Co-founder and Executive Director
The Castleman Disease Collaborative Network