Conference Day One
Tuesday 17th October 2023
8:00 am Conference Registration & Welcome Coffee
8:50 am Chair’s Opening Remarks
Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP
9:00 am The Evolution of Early Access Data Lifecycle
Synopsis
- Understanding the challenges faced by physicians in applying and participating in EAPs
- Designing strategies for engaging with patients & physicians and incorporating their feedback
- Incorporating considerations for local ethics committees and internal hospital approvals during EAP design and implementation
9:30 am Panel Discussion: Enhancing Patient Engagement in Before, During & After Managed Access Programs
Synopsis
- Displaying the positive societal impact of compassionate use for healthcare systems
- Collaborating with patient groups to increase awareness and understanding of managed access programs
- Increasing patient engagement increased sessions and collaboration with patient advocacy groups
10:15 am Speed Networking
Synopsis
Bump elbows with your fellow EAP leaders! This is your opportunity to network and forge new contacts with peers in the industry. Join speed networking to meet a broad spectrum of attendees at the summit, and exchange details to catch up later in the event.
10:45 am Morning Break
11:15 am Panel Discussion: Navigating Country-Specific Pathways for EAPs
Synopsis
- Understanding country-specific regulatory pathways for EAPs
- Devising strategies for manage inspections from different health agencies
- Meeting the requirements of each country in which EAPs are ran
12:00 pm Launching an EAP in Germany
Synopsis
- Understanding the operational considerations for the set-up of an EAP
- Outlining insights and lessons learned
- Leveraging strategic rational and key takeaways
12:30 pm Lunch Break & Networking
1:30 pm Outlining Current Attempts in Harmonising Compassionate Use In Europe
Synopsis
- Overviewing pain points in offering compassionate multi use in the EU
- Understanding how to navigate in a complex stakeholder environment
- Sharing experience and methods applied to remaining complaint while running EAPs in Europe
Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP
2:15 pm Considerations for Post-Trial Access Approach and Policy
Synopsis
- Ethical approach to Post Trial Access, ensuring continued access to patients benefiting from treatment
- Regulatory considerations and country specific case studies
- Learnings for company policy development and operational approach
3:00 pm Afternoon Break & Networking
Planning Considerations to Deliver a Streamlined, Equitable & Efficient EAP
3:30 pm Panel Discussion: Moving Quickly After a Request for a Compassionate Use Programme
Synopsis
- Strategies for efficiently managing and prioritising urgent patient requests
- Developing a streamlined process for handling exceptional cases
- Collaborating with stakeholders to facilitate rapid decision-making and access to treatment
4:00 pm Effectively Implementing a Programme: Small Biotech’s Best Practices and Strategies
Synopsis
- Carefully planning the programme’s scope, objectives, stakeholders, and project plan with timelines and milestones.
- Balancing cost, expertise, capacity, and control when deciding whether to develop the programme in-house or outsource it to a vendor.
- Allocating the necessary resources, including personnel, technology, and funding, and identifies effective strategies for allocation.
4:15 pm Revolutionising Early Access Programs: The Power of a Patient-Centric Approach
Synopsis
Fit-for-Patient Home Healthcare: Delving into the transformative potential of patient-centric strategies in home healthcare and amplifying effect on early access programs
Real Success Studies & Actionable Solutions: Actual case studies and success narratives to extract insights and effective strategies for home-based, patient-centric early access approaches
Forecasting the Future: Anticipating challenges and trends influencing patient-centricity in upcoming early access trials
4:45 pm Maximising the Benefits of Access Programs for Patients and Stakeholders
Synopsis
- How to define the objectives of the program and ensure they align with the overall goals of the organisation.
- Design to meet the needs of all stakeholders including patients.
- Monitoring programme outcomes and how to deal with remaining uncertainties