Join Us for a Full Day of Interactive Hands-On Learning!
Available Only to All-Access Pass Holders
Take a deep dive into the world of clinical research, with professional development trainings designed to help you discover the latest strategies for clinical operations and clinical quality, ensuring inspection readiness, and streamlining operations and technology. With expert trainers leading interactive sessions, you'll walk away with valuable insights, practical tools, and actionable strategies to implement in your own work. Don't miss this opportunity to collaborate with your peers and take your professional skills to the next level!
Morning Workshops
Wednesday, September 25, 2024 | 8:30AM - 12:00PM EDT
Measure Clinical Quality
Join us for an interactive workshop designed for clinical operations and clinical quality professionals seeking to enhance their analytical approaches to measuring quality. Structured around three main topics—Understanding the Data & Reporting Landscape, Optimizing Organizational Structure and Governance, and Navigating Change Management—we will embark on a collaborative journey to assess the current state of your organization's quality analytics.
- Delve into the core components of quality analytics, moving from theoretical concepts to practical implementation strategies
- Engage in group discussions, brainstorming, and actionable planning
- Learn from industry experts' real-world implementations
- Craft tailored elevator pitches for organizational advancement
- Leave with a clear roadmap for impactful quality analytics progression
Workshop Leaders:
- Kevin Richards, M.Sc., Director, Analytics & Insights, AstraZeneca
- Luke Cash, PhD, Associate Director, Analytics & Insights, AstraZeneca
Risk-Based Auditing of Sites
During this hands-on learning experience, we’ll work through different scenarios to understand how to use audits as a tool to independently evaluate study readiness for inspection, how information from different processes feeds into optimal selection of clinical sites for audit, and the different risk factors that impact that selection. Perspectives of both QA, Clinical Operations, and Clinical Monitoring are discussed.
Gain Insight into Clinical Study Quality by Focusing Site Auditing Efforts to High-Risk Areas
- Understand why and when routine GCP audits should take place and their purpose
- Identify the benefits of clinical site audits for overall inspection readiness
- Discus how to to identify site-level risk factors (data driven ‘red flags’)
- Outline the process of evaluation of risk factors leading to selection of clinical sites for audit
- Understand how other factors beyond enrollment impact site selection for the audit
Workshop Leaders:
- Anna Borowiecka, Director, Quality Assurance, Corcept Therapeutics
- Eliza Gabryjelczyk, Director, Evidence Program Management, AstraZeneca
- Adam Rytko, Quality Assurance Director, SolasCure
Afternoon Workshops
Wednesday, September 25, 2024 | 1:00 - 5:30PM EDT
Clinical Technology Innovation Day
Presented by IQVIA Technologies
COMPLIMENTARY FOR ALL PHARMA, BIOTECH, AND DEVICE COMPANIES
Join leaders from IQVIA Technologies, industry experts, and a group of your peers to tackle clinical trial technology challenges head-on. This session is designed to provide insights into the evolving landscape of clinical technology and its impact on clinical development.
Understand How New Clinical Technologies are Driving Innovation, and How to Leverage Them to Improve Clinical Development Productivity
LEARN MORE ABOUT INNOVATION DAY>>
Innovation Day Leaders:
- Melissa Easy, VP Commercial, Digital Products & Solutions, IQVIA Technologies
- Murray Aitken, SVP & Executive Director, IQVIA Institute for Human Data Science, IQVIA Technologies
- Zahiah Gueddar, Senior Director, Commercial, IQVIA Technologies
- Tim Riely, VP, Clinical Data Analytics, IQVIA Technologies
- Anthony Mikulaschek, VP, Commercial Strategy, IQVIA Technologies
- Nicholas Whitney, Senior Director, Trial Management Solutions, IQVIA Technologies
Relationship Management and Oversight
As regulatory authorities continue to focus on demonstrating oversight, to ensure you are inspection ready, we first must understand what those responsibilities are, who is responsible, and how is it documented.
Define the Scope of Responsibilities of the Trial Sponsor and Outsourced Partners, and Strategies for Optimizing the Relationship to Ensure Clinical Success
- Clearly outline the operational and compliance responsibilities of the trial sponsor compared with those of the CRO
- What are the common misconceptions?
- Evaluate best practices for overseeing your clinical partners and how and when to establish that
- Discuss the functional area(s) that should be responsible for oversight at the trial sponsor and what that looks like
- Analyze strategies for documentation and what kinds of agreements need to be in place with clinical partners
- Identify inspection findings related to oversight and what could have been done differently
Workshop Leaders: TBD
