Explore the Agenda
8:00 am Morning Coffee & Check-in
8:55 am Chair’s Opening Remarks
Integrated Evidence Planning Across the Drug Development Lifecycle to Shape Development & Evidence Strategy
9:00 am Bringing RWE Upstream: Using AI & Real-World Data to Accelerate Early Clinical Development Decisions
- Explore how RWE can move beyond traditional pre- and post-launch applications to support earlier decisions around patient selection, tumour selection, biomarkers and trial design
- Lessons from pilots on how AI and advanced analytics can enable rapid feasibility insights and analysis of large, complex datasets and where traditional statistical approaches remain more effective
- Navigate the organisational change, cross-functional education and governance needed to embed RWE and AI into early development
9:30 am Using RWE to Inform Clinical Development and Designing Trials Around the Right Patients, Endpoints & Assumptions
- Leverage RWD earlier in clinical development to assess patient populations, inform inclusion and exclusion criteria, and ensure trial designs reflect real-world clinical practice
- Use real-world insights to challenge critical trial assumptions, from patient representativeness and stratification factors to expected treatment effects and endpoint selection
- Support evidence-based go/no-go decisions by identifying where RWD can strengthen Phase III planning
10:00 am Morning Break & Networking
11:00 am Building an Early RWE Strategy to Strengthen Market Access, HTA & Reimbursement for High-Cost Rare Disease Therapies
- Explore how early assessment of local patient populations, treatment pathways, unmet need and local healthcare clinical practice can shape an effective RWE and market access strategy
- Examine how conducting local RWD studies ahead of HTA and reimbursement negotiations can provide the evidence needed to understand the evolving treatment landscape and support payer discussions
- Navigate the challenges of generating meaningful RWE in rare diseases where patient populations are small, data availability is limited and HTA:s can vary significantly between markets
11:30 am Exploring External Control Arms & Target Trial Emulation to Strengthen Real-World Evidence Generation
- Explore the evolving role of external control arms and target trial emulation in generating robust evidence from real-world data
- Discuss the data and practical considerations involved in applying these approaches and building confidence in the evidence generated
- Share perspectives on where these approaches can add value within evidence generation
12:00 pm Lunch Break
Navigating Regulatory & HTA Pathways to Strengthen RWE Acceptance Across Europe
1:00 pm RWE Confessions: What Got Accepted, What Didn’t & What We Learned
This candid, peer-to-peer session explores the real-world experiences behind regulatory and HTA acceptance, giving attendees the opportunity to share challenges, setbacks and lessons learned.
- Share an RWE approach, study design or evidence package that didn’t get the response you expected from regulators or HTAs
- Discuss what challenged acceptance, what you changed and what ultimately worked
- Compare experiences across markets and therapeutic areas to uncover practical lessons for building more robust, submission-ready RWE
1:45 pm Aligning RWE & Regulatory Strategy From the Start to Build Submission-Ready Evidence & JCA Readiness
- Explore why RWE submission planning needs to begin alongside regulatory strategy rather than being developed retrospectively once evidence gaps have already emerged
- Identify which RWE requirements, data sources and methodological considerations should be anticipated early to ensure evidence generated throughout development can support future submissions
- Assess how population differences, data quality and representativeness can affect algorithm performance across healthcare settings and create risks when models are transferred between populations
2:15 pm Translating RWE Into Compliance-Ready Evidence by Strengthening Medical Writing, Transparency & Regulatory Acceptance
- Translate complex RWE analyses into clear, scientifically rigorous evidence packages that meet regulatory expectations
- Navigate the methodological and reporting challenges of communicating observational evidence while maintaining transparency and reproducibility
- Explore how evolving regulatory expectations and increasing evidence volumes are changing the role of medical writing in RWE
2:45 pm Afternoon Break & Networking
Demonstrating Strategic Value & Securing RWE’s Seat at the Table
3:30 pm Unlocking the Strategic Value of RWD Through Organisation-Wide Data Literacy & Change
- Explore how data stewardship and organisation-wide data literacy can help teams better understand, assess and select real-world data for different evidence needs
- Share practical learnings from building internal training and change initiatives that improve how teams across the organisation use and evaluate RWD
- Examine how embedding better data practices across the business can increase data utilisation, strengthen RWE generation and demonstrate the strategic value of RWE beyond the evidence function
4:00 pm Prioritising RWE for Impact Moving Beyond “More Studies” to Higher-Value Evidence
- Rethink how RWE projects are prioritised to focus limited resources on evidence that can meaningfully influence strategic, clinical, market access and business decisions
- Shift from volume to value by identifying when fewer, more strategically focused studies can generate stronger evidence and deliver greater impact across the product lifecycle
- Build the case for earlier RWE investment by demonstrating how evidence generated earlier in development can strengthen the value proposition and inform critical decisions before launch
4:30 pm IMPACCT Problem-Solving Clinic: Winning Leadership Buy-In for RWE: Sharing Strategies to Secure Investment & Influence
This interactive session puts your current RWE challenges at the centre of the discussion. Bring a real challenge you’re facing and work with peers to pressure-test your approach, share what has worked and find practical ways forward.
- Bring a live challenge around securing leadership buy-in, demonstrating RWE value or winning investment
- Work in small groups to pressure-test your approach, share experiences and identify alternative strategies
- Take away practical solutions and tactics that you can apply to build influence, strengthen your business case and secure support