Real World Evidence and Data Standards
This track showcases the most important initiatives in artificial intelligence, machine learning, real-world evidence, big data.
We will examine how and where these new technologies could and should be incorporated into drug development, approval, post authorisation studies and reimbursement processes, unlocking their potential and cost-efficiencies for the various stakeholders throughout the value chain.
Who is This Track Designed For?
Professionals involved in generating, using and evaluating real-world evidence, data specialists, observational study managers, informatics (bio and medical), data standards, data quality, clinical data management, clinical trial design, clinical operations, electronic health records and other data sources, submissions, health economics outcomes research and biostatistics. It will also benefit software developers, solution providers and device professionals..
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Alison Cave, PhD
Chief Safety Officer
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Patrice Verpillat, DrMed, MD, PhD, MPH
Head of Global Epidemiology
Merck Healthcare KGaA, Germany
Day 1: Tuesday, March 29th
Global Data to Generate Real-World Evidence: Data Technologies For Aggregation and Harmonization of Siloed Data
Day 2: Wednesday, March 30th
Utility and impact of RWD in COVID 19
Enabling AI in Healthcare - the Gaps between State of Science and Regulatory Standards
Developing a Quality Management Checklist to Support Audits of Real-World Data (RWD) Used in Regulatory Submissions
Day 3: Thursday, March 31st
Role and Value of Real-World Data and Real-World Evidence in the Life Cycle of Non-Prescription Medicines
Why is Generating Integrated Evidence in Challenging in Rare Diseases?
DIA Europe 2022 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.