Explore the Agenda
7:00 am Check-In & Coffee
Workshop Name
8:00 am Workshop A: Early Access Programmes 101: Core Principles & Practical Insights for Success
- Mapping the various early access programmes, including compassionate use, expanded access, and right-to-try, along with key regulatory and eligibility differences and the specific nuances to be aware of
- Learn how to engage with critical internal and external stakeholders, from medical and regulatory teams to healthcare providers and patients, ensuring alignment throughout the programme
- Explore the fundamental elements that determine the success of your first EAP, such as patient safety, regulatory requirements, and resource planning, laying the groundwork for future expansion
Workshop Name
8:00 am Workshop D: Implementing & Managing Paid-for Programmes in Early Access
- Deciding on the appropriate approach for your programme, charged versus free of charge
- Evaluating the pros and cons of paid-for programmes in comparison to other early access pathways
- Exploring a detailed case study of a paid-for programme, showcasing successes, challenges and key takeaways
- Preparing your organisation for a paid programme, understanding the financial and operational implications of paid programmes
10:00 am Morning Break & Networking
Workshop Name
10:45 am Workshop B: Designing a Robust Structure for Your First EAP Rollout
- Building the right structure for your EAP by establishing the optimal internal team, defining roles, and determining resource needs for a successful launch
- Ensuring compliance and documentation by understanding the legal and regulatory framework and preparing the required documentation to meet standards
- Setting up operational oversight by putting systems in place to manage patient orders, track progress, and ensure smooth day-to-day execution
Workshop Name
10:45 am Workshop E: Humanitarian Programmes & Health Equity in Early Access: Advanced Strategies
- Aligning humanitarian efforts with early access strategies to ensure vulnerable populations receive timely treatment
- Addressing logistical, regulatory, and political challenges to implement programmes in crisis stricken or low-resource environments
- Partnering with NGOs, governments, and the private sector to create sustainable models for equitable access in humanitarian settings
12:45 pm Lunch Break & Networking
Workshop Name
10:45 am Workshop B: Designing a Robust Structure for Your First EAP Rollout
- Building the right structure for your EAP by establishing the optimal internal team, defining roles, and determining resource needs for a successful launch
- Ensuring compliance and documentation by understanding the legal and regulatory framework and preparing the required documentation to meet standards
- Setting up operational oversight by putting systems in place to manage patient orders, track progress, and ensure smooth day-to-day execution
Workshop Name
10:45 am Workshop E: Humanitarian Programmes & Health Equity in Early Access: Advanced Strategies
- Aligning humanitarian efforts with early access strategies to ensure vulnerable populations receive timely treatment
- Addressing logistical, regulatory, and political challenges to implement programmes in crisis stricken or low-resource environments
- Partnering with NGOs, governments, and the private sector to create sustainable models for equitable access in humanitarian settings
3:45 pm End of Workshop Day
No day selected
No day selected
No day selected