8:00 am
Coffee & Registration
8:50 am Chair’s Opening Remarks
Navigating the Logistical Hurdles to Maximise Success
9:00 am Panel Discussion: Planning an Early Access Programme to Avoid Delays & Minimise Patient Risk
Synopsis
- Establishing a plan before early access requests arrive
- Anticipating costs to guarantee the required resources remain affordable
- Building and maintaining relationships with vendors
9:45 am Implementing an Early Access Programme as a Start Up in France
Synopsis
- Clarify why an Early Access Programme makes sense
- Manage all related activities when an EAP is led by a start up
- Clarify the new French system for early access programmes including the opportunity to get indemnity
10:15 am
Morning Break
11:00 am
Anticipating Supply Requirements & Timeframes to Minimise the Response Time to a Request
Live Virtual Presentation
Synopsis
- Balancing supply requirements for trials and early access programmes
- Predicting early access request volume to ensure supplies are available
- Acting quickly when a request comes in
11:30 am Managing the Supply Chain: “The first to be asked, the last to be thanked”
Synopsis
- Setting up the program and navigating the logistical hurdles
- Considerations for pack types, country scope, label modifications and other
restrictions - Supply models during the Expanded Access Program cycle
12:00 pm
Lunch Break
Ethical Considerations
1:00 pm Interactive Group Discussion: Challenges & Solutions to Real World Data Collection in Multiple European Countries
Synopsis
- Addressing the challenges European regulations pose for data collection
- Managing patchy data outcomes from early access programmes
- Reducing the impact of lost knowledge when data collection for a specific rare disease or sub-population is declined
2:00 pm Understanding the Ethical Considerations of Running an Expanded Access Programme
Synopsis
- Rethinking patient selection when resources are limited
- Overcoming the hurdles of small datasets when establishing an early access programme
- Using early access programme to reach patients with unmet medical needs in all European countries
2:30 pm
Afternoon Break
2:45 pm Roundtable Discussion
Synopsis
This interactive session gives you the opportunity to be part of the discussion, share ideas, and learn from your peers.
Choose the table most relevant to you, and get ready to be part of this conversation:
- Understanding Which Language is Required to Run an Early Access Programme in Multiple Countries
- Harnessing Different Technologies to Streamline Early Access Programmes
- Considerations for Planning & Running a Rare Disease Early Access Programme