Day 2 - EST/EDT (Eastern Daylight, GMT-4)
Day 2 - EST/EDT (Eastern Daylight, GMT-4)
- How GS1 Standards work: harnessing the power of standards to enhance patient safety and traceability
- Combining GS1 standards to streamline business processes and traceability
- Concepts around global standards for clinical trials that impact IRT: from label standards with the clinical site, to data messaging integrations standards
- Hans von Steiger - Group Leader, Clinical Supply Chain Management, Pfizer
- Case study insight into trial: disease area, phase, the rationale for flexibility etc
- Details on practicalities, challenges of the trial
- Insight into how IRT was leveraged to hold the study / do something innovative
- Jasvinder Osan - VP - Business Development, S-CLINICA
- Irena Seredina - Executive Director, S-CLINICA
- How do we decide what data will be recorded in the IRT system?
- Benefits and challenges of maintaining TE data within the IRT
- Pros and cons of automating TE decisions within the IRT
- Benefits and challenges of a TE module integrated with external systems
- Sydney McElroy - Senior Project Manager, IRT, CSL Behring
- Brad Braunecker - Senior Director - IWRS Development & Site Support, Eli Lilly
- Lucas Miller - Director, Project Management, ICON Interactive Response Technology (IRT)
- Marc Lava - RTSM (IRT) Product Owner, Janssen
This talk will explore the evolving role of RTSM as more Pharma and Biotech companies of all sizes begin to realize the risks and inefficiencies associated with manual management of inventory, bulk batch genealogy and GMP / Release Activities. Enabled by the GS1 issuance of Clinical Trial Electronic Messaging Standards, the industry is experiencing a surge in adoption of enterprise-based supply chain solutions.
- How does RTSM fit into the bigger picture and what does this ERP based model mean for RTSM?
- How can we simplify the transition to this new model?
- How can we optimize this new model to dramatically improve efficiencies across the end-to-end supply chain?
- Bart Nicholson - Director Product Management (IRT), Signant Health
- Barry Moore - Head of RTSM, GSK
- Whiteboard session: examining the drug return process and potential challenges
- Examining the perfect model vs reality: common challenges and practical approaches
- Does IRT need a change in the way destruction is shown in the system?
- Drug and country specific scenarios: How to account for drugs being thrown away at site? Or expired drugs that are not allowed to leave the country?
- Practical approaches to manage site variances: how do you ensure accountability?
- Dawn Sorenson - Director, IRT Center of Excellence, Daiichi Sankyo
- Tom DeLiso - Associate Director, RTSM, Janssen
- Amy Sonderman - IRT Expert, Clinical Trial Supplies Unit (CTSU), Boehringer Ingelheim Pharmaceuticals, Inc
- Maria Napoliello Humagain - Director, Clinical Supply Technologies, Arcus Biosciences
Join us for a fireside chat with with Poxy Clinical and a leading Sponsor as they unveil how their partnership has shaped the future of User Acceptance Testing (UAT) and its pivotal role in Interactive Response Technology (IRT) implementations. This engaging session will delve into:
- Best practices for a successful UAT framework
- Building a resilient and high-performing UAT team for excellence
- Adapting your UAT approach for an efficient IRT implementation that supports all study designs
- Engaging your UAT partner to ensure accurate system requirements
- Susan Vong - President, Poxy Clinical – UAT Services
- Diandra Lawson - Senior Manager, Clinical Trial Material Management, Sumitomo Pharma
The success of your clinical trial in part relies on a positive experience for your sites and patients. As clinical trials become more intricate and run longer, sites are experiencing higher turnover rates than ever before. Join us as we discuss evolving trends in daily user support needs/requests.
- Provide an overview of industry trends that are prompting an evolution in your IRT support needs
- Discuss daily expectations from an IRT support team across the varying users within the system and how that is being influenced by our day to day lives
- We’ll review the types of support requests that are prevalent and trends emerging as a result of these evolving needs
- Discuss why IRT support should be included vendor selection decisions and governance reviews as well as how to do it
- Robert “Bob” Weney - Director, Global Client Services, Almac Group
- Understanding ICH E6(R3) Good Clinical Practice on Clinical Systems
- Ensuring compliance with GCP as part of IRT design and build
- Work in groups through some common challenges and discuss how best to respond
- Gayle Flynn - Engagement Delivery Partner - Life Sciences, Cognizant