Day One
Wednesday - February, 28 2024
8:20 am Registration & Morning Coffee
Ensuring Data Acceptability by Regulatory Agencies to Streamline Candidate Approvals
9:20 am Chair’s Opening Remarks
9:30 am Panel: Addressing The Industry’s Challenges with Data Quality, Access & Regulatory Acceptance Across Europe
Synopsis
- Exploring the evolving European regulatory framework and its impact on the acceptance of real-world evidence in drug development and clinical trials
- Addressing data privacy concerns and ensuring compliance with European data protection regulations
- Manoeuvring methods to break down databases and improve data quality for more effective real-world evidence utilisation
Moderated By: Lene Hammer-Helmich, Director, Head of RWE & Epidemiology, Lundbeck
10:15 am Speed Networking
Synopsis
As the real world evidence community is united for the first time, this valuable session will ensure you get the chance to reconnect with peers and make brand new connections too! This structured networking opportunity will pair you with fellow attendees for several 3-minute introductions, ensuring you have the opportunity to meet and network with your academic and industry colleagues!
10:45 am Morning Break & Networking Coffee
Safeguarding Data Quality to Confirm Data Readiness
11:15 am Uncovering Lessons Learned in Navigating Real World Data Challenges for Ophthalmic Disorders
Synopsis
- Exploring the disparities between real world evidence and clinical trial results, emphasizing the importance of understanding that real-life scenarios often yield different outcomes, and discussing key takeaways for leveraging real world data effectively in healthcare decision-making
- Optimizing real world data integration at the initial stages, including data extraction from electronic patient records and addressing approval processes, missing data, and interpretation challenges in ophthalmologic disorders
- Covering lessons learned from conducting data audits for electronic medication records, emphasizing the do’s and don’ts, and highlighting areas where errors can occur, along with strategies for continuous improvement
11:45 am Mastermind Session: Clarifying the Definition of Real World Evidence Across Different Sized Companies
Synopsis
This session offers you the opportunity to uncover the differences and similarities of the use of the term real world evidence in your internal-facing role. You will spend 20 minutes soundboarding these ideas and challenges that arise with your peers and spend that last 15 minutes of the session feeding back the points discussed and recommendations for next steps to mitigate any challenges you face or best practices you’ve uncovered.
• Exploring how various biopharma companies define and perceive real world evidence, highlighting commonalities and differences
• Discussing ongoing efforts and industry initiatives aimed at establishing a standardized framework for real world evidence across biopharma organizations
• Assessing next steps that need to be taken
12:30 pm Lunch Break
Enhancing Data Access Across Europe by Improving Collaborative Frameworks
1:30 pm Enabling Large-Scale Analysis of Real World Data in Europe
Synopsis
• Understanding how we can scale up real word evidence generation
• Provide lessons learned from EHDEN and DARWIN EU®
• Discuss future opportunities
2:00 pm Poster Session & Refreshments Break
Synopsis
Witness some of the latest and greatest clinical research applications of real world evidence by drug developers, academics, and researchers in this spotlight poster session
Enhancing Data Access Across Europe by Improving Collaborative Frameworks
3:00 pm Leveraging Nordic Data Cohorts for Advanced Healthcare Insights
Synopsis
- Exploring the potential of using aggregated data from multiple Nordic countries as a unified cohort for healthcare research and real-world evidence generation
- Delving into the nuances of Nordic data sources, discussing the challenges related to data completeness and validity, while highlighting the unique opportunities for research
- Addressing the issue of lengthy application times for accessing Nordic health data and proposing strategies to streamline the process, enabling faster and more efficient data utilization
3:30 pm Efficient & Secure Use of Health Data Across Borders – Nordic Experience
Synopsis
- Exploring the collaborative efforts among Nordic countries and global partners, focusing on the importance of remote data collection and its relevance in the biopharma landscape
- Delving into the complexities of GDPR and its impact on cross-border data sharing
- Learning how different countries are piloting projects to facilitate secure data transfer and collaborative research while respecting privacy regulations