Conference Agenda

Expanded Access Programmes - Day 2

Day 2: 2nd March 2022


  • Background and scope of early access approaches
  • Identifying challenges faced by Applicants of PRIME and Breakthrough therapies
  • Scientific elements and regulatory tools available to address the challenges and explore theflexibility within the current regulatory systems
  • Key considerations to ensuring a successful program
  • How MAPs fit with an orphan launch strategy
  • How to design them effectively taking all stakeholders into account
  • Best practice in implementation and management
  • When does a MAP end?

Senior Representative, Durbin PLC, part of uniphar group 



  • Navigating the diverse regulatory differences between EU countries
  • Understanding the different approaches to approval procedures for early access
  • Important considerations before implementing EAP in European countries
  • The need for greater regulatory harmonisation to widen the early access
  • What are the logistical bottlenecks encountered from the start of COVID-19
  • How can you predict demand and guarantee product sustainability to set up and maintain EAP?
  • How to effectively communicate with different stakeholders in preparation to EAP
  • In an era where “real-world data” is increasing of interest, what limitations should exist?
  • Data collection guidelines within early access programmes in various regions
  • Ethical consideration and operational challenges in conducting data collection
  • Benefits of collecting RWD within early access programmes


  • Challenges facing the reimbursement system
  • Understanding different payer strategies currently in place
  • Alternative access schemes offer flexibility to
  • policymakers but often lack transparency and clearrules.
  • The uncertainties allow for dynamic responses to weaknesses in the main drug approval and reimbursement systems
  • Strategic considerations and best practices to facilitate Expanded Access Programmes
  • What are the comprehensive approaches that can support both clinical development and medical governance objectives
  • Embracing patients need and physicians input to increase uptake and quality of EAP
  • Various stakeholders engagement to leverage communication between pharma, clinician and patient organization
  • Advantages of a collaborative patient-pharma relationship 
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