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Informa

20-22 April 2020
Barcelona, Spain

Implement Successful Access Programmes for Investigational Therapies while Navigating Country-Specific Regulations and Gathering Real-World Data

Global considerations for a variety of early access programmes with an emphasis on collaborating with patient advocates and implementing a holistic programme from beginning to end.

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What to Expect

A Snapshot of our Elite Speaker Line-Up

Global Regulations
Martine Zimmermann, Global Head of Regulatory Affairs, Alexion Pharmaceuticals

European Policy Spotlight
Pedro Franco, Director of Europe for Global Regulatory and Scientific Policy, Merck; formerly with EMA

Stakeholder Collaboration
Beverly Harrison, Head of Patient Support, Office of the Chief Medical Officer, Johnson & Johnson

Operationalising MAPs
Ramona Reichenbach, Global Medical Governance Lead, Managed Access Programs (MAPs), Novartis

Partnering with Patients
Theodora Weisz, Patient Advocacy Director, Europe, Akcea Therapeutics

Patient Advocacy Perspective
Mimi Choon-Quinones, Senior Vice President, Global Policy, Advocacy, Medical Access and Research, International Myeloma Foundation

Heightened Emphasis on Rare Disease, Orphan Drug and Cell & Gene Therapy Progress

Choose Between Two In-Depth Workshops:


A. Policy Spotlight — Accelerated Pathways and Approvals for Rare Diseases

B. Commercialisation Strategies for Novel Medicines — A Look at Orphan Drugs and Cell and Gene Therapies

Inaugural Managed Access Programmes Blueprint Showcase –

An End-to-End Analysis from Design to Post-Trial Access

I. Explore Innovative Models for Managed Access Programme Design
II. Effectively Integrate Managed Access Programmes into Clinical Development
III. Navigate and Operationalise Managed Access Programmes Internally
IV. Address End of Life Cycle Actions to Advance Access

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Get the latest information on Informa Connect–CBI’s 5th Annual Managed Access Programmes and Accelerated Pathways.

2019 HIGHLIGHTS!


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