Day One
Tuesday 10 June, 2025
8:00 am Check-In + Badge Collection + Light Breakfast
8:50 am Chair’s Opening Remarks
Maximizing Data Quality to Enhance Quality of RWE
9:00 am Timely, Tested, Trusted: Proactively Generating Robust RWD Insights
Synopsis
- Leverage insights from past analyses to develop future-focused RWD analysis strategy
- Deploy data pipelines and automation to efficiently deliver robust RWD insights across indications
- Build trust with cross-functional stakeholders through proactive communication of RWD insights
9:30 am Addressing Data Representativeness & Relevance to Improve the Applicability of RWE to Support Policy Decisions
Synopsis
- Examine approaches to mitigate biases and enhance the inclusivity of datasets to better reflect diverse patient populations
- Understand how to tailor real-world evidence to meet the specific requirements of policymakers and regulatory bodies
- Explore methods to identify and prioritize data sources that align with current healthcare challenges and decision-making frameworks
10:00 am Building Trust in (RWE) With a Focus on UK & Nordic Data Sources in Reference to EU/EMA & NICE Guidelines for RWE
Synopsis
- Face validity of secondary health data
- Validation studies & disease algorithm development
- Transparency and public trust in the use of health data
10:30 Speed Networking
Synopsis
This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the real-world evidence experts to stablish meaningful business relationships.
11:00 Morning Break
Consolidating Cross-Functional Collaboration to Improve Effectiveness & Efficiency of RWE Studies
11:30 am Cross-Functional Collaboration Techniques to Improve Coordination Between R&D, Market Access, & Regulatory Teams
Synopsis
- Explore strategies to establish clear and consistent communication pathways between R&D, market access, and regulatory teams to align goals and timelines
- Learn best practices for sharing real-time data and insights across functions to drive informed decision-making and streamline development processes
- Discover how to foster a collaborative culture, ensuring that all teams work together efficiently towards common objectives, from early development through to market access
12:00 pm Elevating Strategic Collaboration Between Global and Local Teams to Enhance Coordination & Efficiency in Evidence Generation
Synopsis
- Explore strategies for aligning global and local teams to ensure consistency in evidence generation while addressing regional needs and regulatory requirements
- Learn how to streamline communication and workflows between global and local teams to enhance efficiency and reduce duplication in evidence generation efforts
- Discover techniques for incorporating local data and patient insights into global evidence strategies to ensure broader relevance and applicability
12:30 Lunch
1:30 pm Roundtable: Strategies for Operationalizing JCA Requirements Through Practical Steps to Integrate JCA Processes into Your Organization
Synopsis
- Break down the Joint Clinical Assessment (JCA) requirements to understand their implications for evidence generation and submission
- Explore actionable steps to align organizational workflows, timelines, and resources with JCA standards and expectations
- Learn how to foster collaboration between regulatory, clinical, and market access teams to streamline JCA integration and ensure compliance
2:00 pm Strategic & Practical Execution of RWE Tactics to Advance Cross- Functional Collaboration
Synopsis
- Navigating issues when working with medical affairs teams and vendors
- Proposed business case to improve Approach to RWE
- Case study led insights
2:30 pm Afternoon Break & Poster Session
Synopsis
Witness some of the latest and greatest research in the RWE and evidence generation field by drug developers, academics, and researchers in this spotlight poster session!
3:00 pm Breaking Down Silos for Optimized & Impactful Integrated Evidence Generation
Synopsis
- Explore strategic partnership to enhance the IEG plan
- Understand the value of creating a culture of collaboration to enhance the impact and effectiveness of RWE
- Challenges with implicating these strategies into a workflow
3:30 pm From Challenges to Best Practices in Conducting Multi-Center Secondary Data Research with OMOP CDM
Synopsis
- Must-haves for future-proof medical evidence generation.
- Fit-for-purpose data, data infrastructure and governance.
- Examples from case studies in oncology