Conference Day Two
9:25 am Chair’s Opening Remarks
Determining the Role of Real-World Data in EAPs
9:30 am Leveraging AI Tools & a Digital Patient Community to Advance Expanded Access Programs
Synopsis
• Using a digital patient community to incorporate a centralized way to identify way patients with the highest need
• Mitigating the legal and data privacy complications
• Setting up an expanded access through value-based organisations to obtain a large community of patients and carry this out with ease as it’s completed through one system
10:00 am Roundtable Discussion: Is Collecting Data Vital for Running a Successful EAP?
Synopsis
• Collecting data to help pricing and reimbursement decisions whilst remaining cautious to not impact regulatory strategy
• What are the necessary ethical considerations and protocols needed to be in place to collect data?
• What are the implications of this for an unlicensed product?
10:30 am Morning Break & Networking
Charting the Path Forward for Clinical Supply Excellence
11:00 am Highlighting Practical Strategies to Successfully Deliver a Project in the Middle East
Synopsis
• Sharing previous experiences on how to navigate the regulations in the Middle East and Africa
• What are the important factors to consider ensuring it runs smoothly?
• Highlighting the lessons learnt from when it hasn’t gone according to plan
11:30 am Panel Discussion: Ensuring Labelling Consistency Across the Supply Chain & Its Accordance with GNP
Synopsis
• Streamlining the labelling process to ensure patients receive the drug in a timely manner
• Establishing clarity and consistency on what’s considered pre-approval access
• Reviewing multinational labelling requirements and seeking guidance for optimal interpretation
12:00 pm Lunch Break & Networking
1:00 pm Licence Withdrawal: Rapidly Pivoting to Ensure Continuity of Care
Synopsis
• Ensuring continued drug supply to several hundred patients
• Effective communication with HCPs and internal stakeholders
• Setting up the internal and external infrastructure to ensure streamlined approach to processing the volume of requests
Overcoming Operational Challenges & Mitigating Data Privacy & Legal Issues
1:30 pm Deep Diving into Processes & Systems for EAP
Synopsis
• Developing a platform for program management
• Partnering with digital teams and vendors
• Reporting metrics and turnarounds times
2:00 pm Afternoon Break & Networking
2:30 pm Navigating & Successfully Setting Up an Expanded Access Program for an Ultrarare Disease
Synopsis
• How do you handle an ultrarare disease?
• How do you get drugs into countries without well-defined regulations
• How do you proceed with continuing a drug within this disease post FDA approval in different countries?
3:00 pm Roundtable Discussion: Informed Consent & Assent: Raising Consciousness About the Importance of Consent
Synopsis
• What are the best practices globally about how you do consent?
• Ensuring patients are fully aware of the risks involved
• Optimizing the circulation of data between patients, physicians, and manufacturers