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

May 3-4, 2017
  • London, England

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

A broad array of key stakeholders are coming together for an in-depth and meaningful discussion on Managed Access Programs 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.

Policy is Propelling Progress as More Biopharmaceutical Products Offer Programs for Compassionate Use and Early Access —
Hear Global Thought Leaders Unite on a Path Forward


Stéphanie Hoffmann
Vice President,
General Manager Europe
Pharmaceuticals Inc.

Erik Tambuyzer, PhD
Chair of the Board
BioPontis Alliance
for Rare Diseases

Sue Harris
Unit Manager
Medicines & Healthcare
Products Regulatory
Agency (MHRA)

Mariangela Demarcus, PhD
Associate Director,
Managed Access Programs,
Ph IV & Medical Strategy
Vertex Pharmaceuticals
(Europe) Limited

Ramana Sonty, MBBS, PhD
Director of Strategy
Janssen Global
Medical Organization

World Showcase — Navigate Country-Specific Regulations
for Access Programs and Expedited Pathways
(EU, UK, U.S., Canada, Japan, Russia and more)

Powerful Programming, Compelling Content
and Knowledge Sharing:

  • Develop a Tailored Roadmap for Accelerating Access to Unapproved Medicines
  • Deep-Dive into Critical Design and Operational Aspects for MAPs to Maximise Value
  • Compare and Contrast Global Expedited Development Pathways (Breakthrough, Sakigake and PRIME)
  • Gain an Inside Look at the J&J and NYU Pilot Program for Establishing Equity in Compassionate Use
  • Examine the International Supply Chain Channel and Navigate the Payment and Reimbursement Policy for Unapproved Medicines
  • Explore Innovative Outreach and Education Efforts to Align with Advocacy Stakeholders and Empower Patients

3-4 May, 2017 | Amba Hotel Marble Arch | London, England