Day 1: ACCESS Programmes Congress

Conference Agenda


Expanded Access Programmes - Day 1

Day 1: 1st March 2022


  • Understanding the challenges in running a global EAP
  • The positive impact of EAP on patients with serious, immediately life-threatening or
  • rapidly debilitating diseases
  • Gain an understanding to increase access to treatment
  • The importance of cross collaborations between stakeholders
  • Introduction to EAP and their differences
  • When does the implementation of the Early Access programme be considered
  • What are the numerous challenges faced in the implementation of EAPs?
  • Key considerations for the successful implementation of early access program
  • Comparison between restriction in disease standard
  • Limitation to the scope of access to drugs
  • Application of use
  • Applies to individual or cohorts
  • Deep-dive into the reality of healthcare access around the world
  • What does the future of health access look like?
  • The interconnected ecosystem where all healthcare stakeholders (patients, carers, HCP’s, pharma, health advocates, politicians, policy makers, technologists, etc.) come together
  • Balancing patient safety with potential therapeutic benefits
  • Physicians perspective and experiences
  • Risks and Rewards to Sponsors (Drug Manufacturer)


  • Should a company avoid any risks to a development program to help a larger number of patientsgain access in the future?
  • How to avoid a negative impact resulting from pre-approval access to investigational medicines
  • Providing affordable access to those receiving the medication when compassionate use end
  • Challenges & Opportunities of a company-wide roll-out of Early Access Programme
  • Strategies & consideration for a successful implementation
  • Established responsibilities from everyone involved to ensure smooth delivery to patients in need
  • The importance of patient advocacy in providing much-needed information on EAP’s available forpatients
  • Collaborating with one another to enable a much richer understanding of patient needs
  • Patient groups’ importance in working with health authorities to advance policies that acceleratepatient access to investigational medicines
  • What are the possible scientific and regulatory approaches to facilitate development?
  • How to create robust quality data packages to enable timely access to medicines for patients
  • Ways to guarantee that patient safety, efficacy and product quality are not compromised
  • A discussion of experiences to date from early access approaches.
  • How important is engaging patient early at the earliest stage in research and development
  • The need for a continuous meaningful dialogue between stakeholders to establish an effective working relationship
  • What are the best practices and ethics behind a successful early access programme?
  • Knowing what motivates the stakeholders within early access
  • Sustaining purposeful patient engagement across the lifecycle of medicines
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