8:00 am
Coffee & Registration

8:50 am Chair’s Opening Remarks

  • Vilem Guryca Global Program Lead & Managed Access, BeiGene

Navigating the Logistical Hurdles to Maximise Success

9:00 am Panel Discussion: Planning an Early Access Programme to Avoid Delays & Minimise Patient Risk

  • Claire Wardell Director, Managed Access Global Medical Affairs, GSK
  • Erin Lambet Senior Director Expanded Access Program Lead, Argenx
  • Isabelle Adeline Chief of Staff, Director PMO, Regulatory Affairs, QA and IP, MaaT Pharma

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

  • Isabelle Adeline Chief of Staff, Director PMO, Regulatory Affairs, QA and IP, MaaT Pharma

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

  • Shirle Zajac Leader of Global Ethical Business, Shortages Response & Managed Access Programs, Teva

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”

  • Vilem Guryca Global Program Lead & Managed Access, BeiGene

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

3:45 pm Chair’s Closing Remarks & End of Conference

  • Vilem Guryca Global Program Lead & Managed Access, BeiGene