What the three days cover

Day 1 – Foundations, innovation, and early development strategy
How RWE is used to assess disease burden, identify unmet needs, and shape product profiles in early development. The day includes a session on current and emerging innovations – including AI, tokenisation, hybrid study designs, and global data partnerships – and a case study on how these advances have shaped early-stage strategy. Participants will also share their own experience of RWE and discuss what brought them to the programme.

Day 2 – Late-stage development and regulatory strategy
The role of RWE in clinical trial planning – site selection, patient recruitment, protocol design – and in regulatory submissions. A case study examines how RWE has supported regulatory decisions, and a group exercise challenges participants to design an RWE study addressing a real regulatory question. The day closes with an optional fireside discussion with an invited guest from a regulatory, payer, or global health organisation, preceded by drinks.

Day 3 – Launch, market access, and lifecycle management
How RWE supports value demonstration, reimbursement submissions to payers and HTA bodies, and post-launch product strategy. A case study explores RWE in payer and policy decisions, and a scenario-based planning exercise gives participants hands-on practice developing an RWE strategy for a product in its post-launch phase. The programme closes with a facilitated reflection on what makes RWE credible and actionable for different stakeholders.

Who should attend

The programme is designed for professionals who generate, evaluate, commission, or make decisions informed by real-world evidence. It is particularly suited to those seeking to broaden their perspective and gain a deeper understanding of how RWE is increasingly critical to informing strategy, innovation, and policy decisions. It is relevant across pharmaceutical and biotechnology companies, healthcare and clinical leadership, public health and epidemiology, health policy and regulation, HTA and market access, global health organisations, academic and research institutions, and consultancy.

Participants will get the most from the programme if they have some familiarity with RWE concepts (even informal), a basic understanding of clinical or observational research, and experience using or commissioning evidence for decision-making. No advanced training in epidemiology, statistics, or data science is required.

Participants will receive a short set of pre-reading materials (approximately one hour) in advance to establish a shared baseline for the case-based discussions.

What you will gain

By the end of the programme, participants will have:

• a structured understanding of how RWE contributes at each stage of the product lifecycle – and how AI and advanced analytics are changing the field
• sharper judgement on when and how to use real-world evidence alongside clinical trial data
• practical exposure to RWE applications in regulatory, payer, and policy contexts through real case studies
• a network of peers and leading experts across industry, academia, and policy

Participants will receive a certificate of completion from the University of Oxford.

How this programme differs

Most RWE courses focus on technical methods such as study design, statistical analysis, and data curation. This programme takes a strategic perspective, exploring how RWE informs decisions across development, regulatory, access, policy, and healthcare contexts. It is designed both for those who use evidence to make decisions and for those who generate evidence and wish to better understand its strategic application and impact.

Programme format

Interactive throughout. The programme combines expert-led sessions with case study analysis, group exercises and scenario planning, peer-to-peer learning, and guest lectures and fireside discussions with leaders from regulatory bodies, payer organisations, and the pharmaceutical and biotech sector.

Facilitators

Richard Hobbs CBE FMedSci is Director of the Oxford Institute of Digital Health and one of the UK's most cited clinical researchers. His work spans cardiovascular disease, primary care diagnostics, and the application of real-world data in health systems policy.
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Sylvia Taylor PhD MPH MBA is Executive Director and Head of RWE and Health Outcomes for Vaccines at GSK, where she leads global strategy for real-world evidence across the world's largest vaccine portfolio. She previously built the RWE team and led the Phase 3b/4 programme for the Oxford–AstraZeneca COVID-19 vaccine at AstraZeneca, contributing to the global distribution of over 3 billion doses.
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Aaron Kamauu MD MS MPH is CEO of Navidence, a platform advancing precision in RWE study design. He previously led healthcare data strategy at Roche/Genentech and real-world data services at Parexel, with expertise spanning protocol design, regulatory submissions, and the integration of real-world data into clinical development.
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Fees and practicalities

The programme fee is £4,500 per participant, including full participation, course materials, catering, and a formal dinner at an Oxford college.

The fee does not include accommodation. A curated selection of discounted rooms at nearby Oxford hotels will be available; booking details will be provided on registration.