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Navigate Global and Country-Specific Regulations and Reimbursement Models for Early and Expedited Access

May 15-16, 2019
  • Amsterdam, The Netherlands

CBI’s 4th Annual Managed Access Programmes and Accelerated Pathways is dedicated to the nuances and complexities of designing and implementing early access programmes. Focused on global considerations for a variety of access management programmes, including, but not limited to: Expanded Access Programmes, Early Access Programmes, Compassionate Use Programmes, Named Patient Programmes and Managed Access Programmes.

A broad array of key stakeholders are coming together for an in-depth and meaningful discussion on Managed Access Programmes where the implications, prevailing policies and current industry approaches are discussed in detail. Don’t miss the opportunity to join your peers and share best practices around providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes.

Featuring Cutting-Edge Topics:

  • Nomenclature Clarification —
    Consensus on Universal Demand for Common Language
  • Navigate Regulation Updates in Europe —
    Latest Changes in EMA and MHRA
  • Discover Latest Legislative Changes in the US and Impact Globally —
    21st Century Cures Act
  • Patient and Physician Spotlight — Hear Directly from Them
  • Programme Spotlight —
    Inside Look at Successful Managed Access Programmes
  • Industry Paradox — Earlier the Access, Harder the Reimbursement
  • Evaluate Country-Specific Reimbursement Models —
    UK, Germany, France, Italy
  • Leverage Real-World Data and Data Capturing to Support the
    Regulatory Approval Process
  • Shine Light on Company-Specific Strategies — Especially Small
    Biotech Companies and Companies with First Product
  • Global Think Tank and Interactive Dialogues for
    Actionable Takeaways!

Previous Attendee Acclaim:

I learned a tremendous amount and have many new perspectives to bring back to my own work. The conference gave me new insights to considerations related to reimbursement and real-world data generation when planning Expanded Access / Pre-Approval Access programs. I look forward to the opportunity to continue to connect with these colleagues.

Early Patient Access Program Lead, Bristol-Myers Squibb

Great insights from a variety of perspectives including
the patients, regulators and manufacturers,
who all addressed real issues.

Vice President, AmerisourceBergen

Very informative conference.
Great speakers and collaborative meeting!

Associate Director, Amicus Therapeutics

After ten years in the expanded access space, I learned something new and heard a lot from the patient’s perspective.

Associate Director, Expanded Access, TESARO

Managed Access Programmes and Accelerated Pathways

Navigate Global and Country-Specific Regulations and Reimbursement Models for Early and Expedited Access

CBI’s 4th Annual Managed Access Programmes and Accelerated Pathways is dedicated to the nuances and complexities of designing and implementing early access programmes. Focused on global considerations for a variety of access management programmes, including, but not limited to: Expanded Access Programmes, Early Access Programmes, Compassionate Use Programmes, Named Patient Programmes and Managed Access Programmes.

A broad array of key stakeholders are coming together for an in-depth and meaningful discussion on Managed Access Programmes where the implications, prevailing policies and current industry approaches are discussed in detail. Don’t miss the opportunity to join your peers and share best practices around providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes.

Featuring Cutting-Edge Topics:

  • Nomenclature Clarification —
    Consensus on Universal Demand for Common Language
  • Navigate Regulation Updates in Europe —
    Latest Changes in EMA and MHRA
  • Discover Latest Legislative Changes in the US and Impact Globally —
    21st Century Cures Act
  • Patient and Physician Spotlight — Hear Directly from Them
  • Programme Spotlight —
    Inside Look at Successful Managed Access Programmes
  • Industry Paradox — Earlier the Access, Harder the Reimbursement
  • Evaluate Country-Specific Reimbursement Models —
    UK, Germany, France, Italy
  • Leverage Real-World Data and Data Capturing to Support the
    Regulatory Approval Process
  • Shine Light on Company-Specific Strategies — Especially Small
    Biotech Companies and Companies with First Product
  • Global Think Tank and Interactive Dialogues for
    Actionable Takeaways!

Previous Attendee Acclaim:

I learned a tremendous amount and have many new perspectives to bring back to my own work. The conference gave me new insights to considerations related to reimbursement and real-world data generation when planning Expanded Access / Pre-Approval Access programs. I look forward to the opportunity to continue to connect with these colleagues.

Early Patient Access Program Lead, Bristol-Myers Squibb

Great insights from a variety of perspectives including
the patients, regulators and manufacturers,
who all addressed real issues.

Vice President, AmerisourceBergen

Very informative conference.
Great speakers and collaborative meeting!

Associate Director, Amicus Therapeutics

After ten years in the expanded access space, I learned something new and heard a lot from the patient’s perspective.

Associate Director, Expanded Access, TESARO