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
- Consider the management of related activities when an early access programme is led by a start-up
- Managing all related activities when an EAP is led by a start up
- Clarify the new French system for early access programmes
- Highlight the reimbursement opportunities in France, and assess whether they can be replicated in other countries
10:15 am
Morning Break
11:00 am Roundtable Discussion: Implementing an Early Access Programme as a Start Up in France
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:
- Consider the management of related activities when an early access programme is led by a start-up
- Managing all related activities when an EAP is led by a start up
- Clarify the new French system for early access programmes
- Highlight the reimbursement opportunities in France, and assess whether they can be replicated in other countries
11:30 am Anticipating Supply Requirements & Timeframes to Minimise the Response Time to a Request
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
12:00 pm
Lunch Break
1:00 pm Managing Supply Chain Logistics
Synopsis
- Forecasting supply availability of treatments and future demand
- Ensuring submissions are made to relevant health authorities in each country
- Discovering steps to take if supply is denied entry at the border
Ethical Considerations
1:30 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
2:15 pm
Afternoon Break
3:00 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
3:30 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