Archives: Agenda
One of the highlights on the agenda is an audience-driven Q&A session on Day 1, Stream A at 5pm, led by Dr. Tonia Jeiter (Associate Director Clinical R&D, Alcon; former Clinical Team Lead at TÜV SÜD), offering practical lessons learned from a notified body perspective on aligning clinical evidence with EU MDR expectations. Drawing on experience from both notified body review and industry execution, the discussion will focus on bridging gaps between reviewer expectations and sponsor realities, and on optimizing clinical trial design and submissions for smoother approvals.
You are invited to submit and upvote questions via Slido by 19 January: Submit your question via Slido (or go to slido.com and enter code # 3184931).
Reducing delays, damage & blind spots: how Tive support pharma companies to actionable visibility to ensure shipments arrive on-time and in full
- IOT and Technology Evolution
- From Reactivity to Proactively saving shipments.
- AI in predictability – The Next frontier
Automating and Enhancing Efficiency through R-Based Solutions
- Design and implementation of an automated Data Management pipeline that standardizes key processes and reduces manual workload across studies
- Lessons learned from developing and deploying the Data Management pipeline across multiple clinical studies
- How automation and reproducible pipelines are shaping the future of Data Management and Clinical Data Science
CASE STUDY: Applying Agentic AI for streamlined data management processes
Chair’s closing remarks
END OF DAY 1 AND NETWORKING DRINKS
VIRTUAL SESSION: RadioPharmaceuticals: Understanding the unique specificities of RadioPharm Trials, and the unique challenges for data management
- Unique Nature of Radiopharmaceuticals in Clinical Trials
- Strategies for Effective Data Management
- Operational Challenges in Trial Design & Execution
- Complexity of Multimodal Data Integration
- Unique Challenges in Data Management
Alliances and partnering solutions for delivery of Data Management in current business landscape
- Key considerations for delivery of a large portfolio
- Challenges and opportunities in the implementation of a new delivery model/framework
- A case study: Internal Vs External Resourcing
Navigating vendor relationships: Keys to clinical data management success
- Vendor Relationships in a Changing Environment
- Best Practices for Successful Vendor Collaboration
- From Vendor to Partner
- Keys to Establish Effective Oversight