Join experts and peers for the Managed Access Programmes and Accelerated Pathways Digital Week running 29 September - 1 October, 2020. This global 3-day series of live webcasts and downloadable resources will provide you with expert insights on operationalising early access programmes to better assist patients in need. A broad array of key stakeholders will prepare in-depth discussions on Managed Access Programmes, where the implications, prevailing policies and current industry approaches are discussed in detail.

To sponsor future digital events, contact .

Day 1: Tuesday, 29 September 2020

Discuss Expanded Access as a Strategic Imperative for Pharmaceutical Companies
3pm CEST / 2pm BST / 9am EDT

  • Deep dive into the continued evolution of expanded access
  • Analyze real-world data as a viable opportunity to showcase value for all stakeholders
  • Benefit from an in-depth case study tying expanded access to real-world data collection
  • Assess key considerations for moving forward and advancing the industry


Dennis Akkaya
Corporate Development

View More Details +

Laying the Foundation — Assess Where Industry Stands Now and What Opportunities Await
4pm CEST / 3pm BST / 10am EDT

  • Revisit the 2019 meeting by regrouping and reviewing last years ‘calls to action’
  • Discover progress that has been made while uncovering key goals and areas for improvement
  • Remain forward-looking to continuously strive for innovations that streamline patient access


Greg Tuyteleers
Senior Director, Global Operations Head - Managed Access
Johnson & Johnson

View More Details +

Policy Spotlight — Accelerated Pathways and Approvals for Rare Diseases
5pm CEST / 4pm BST / 11am EDT

  • Discuss key areas for development, regulatory and access challenges in rare diseases
  • Explore the unique collaboration between different stakeholders during the journey to bring innovative medicines to rare disease patients
  • Understand the main features of orphan regulatory frameworks in major jurisdictions
  • Bridge approval and access to orphan medicines from a market access perspective


Martine Zimmermann
Global Head of Regulatory Affairs
Alexion Pharmaceuticals

María Pascual
Chief Regulatory Officer
Minoryx Therapeutics

Gabrielle Nayroles
Director of Market Access
Voisin Consulting Life Sciences

View More Details +

Day 2: Wednesday, 30 September 2020

Address the Continued Need for Global Patient Access Solutions Following Approval
3pm CEST / 2pm BST / 9am EDT

  • Understand the key elements in a successful transition from early access to post approval and commercial launch, while ensuring seamless patient supply
  • Consider unmet global patient demand and discuss strategies for continued access following a targeted commercial launch


Neil Watson
Director, Business Development

View More Details +

Regulatory Frameworks in the United States and Europe
4pm CEST / 3pm BST / 10am EDT

  • Stay on the pulse of processes, stakeholder perspectives and initiatives being made in different European nations regarding accelerated access
  • Compare and contrast managed access programme design and development dos and don’ts from a former EMA perspective


Pedro Franco
Director of Europe for Global Regulatory and Scientific Policy
Merck; Formerly Scientific Administrator, EMA

View More Details +

Commercialisation Strategies for Novel Medicines — A Look at Orphan Drugs and Cell and Gene Therapies
5pm CEST / 4pm BST / 11am EDT

  • Take an in-depth look at the creation of an Early Value Proposition (EVP), an Evidence Generation Plan and an Orphan Medicinal Product/Advanced Therapy Medicinal Product Innovative Pricing Strategy that meet the requirements of all healthcare stakeholders
  • Discuss how industry can better understand the crucial role of patients and caregivers in rare diseases to promote optimal care
  • Navigate various stakeholder perspectives and benefit from a case study spotlight on Inherited Retinal Dystrophies (IRDs)


David Schwicker
ORPHA Strategy Consulting

Orla Galvin
Director of Research and Policy
Retina International

View More Details +

Day 3: Thursday, 01 October 2020

Collection and Application of Real-World Data (RWD) through Early Access Programmes in Europe
3pm CEST / 2pm BST / 9am EDT

  • Examine European regulatory frameworks and guidelines for the collection and application of RWD in EAPs
  • Hear examples of RWD mobilization transforming the patient journey
  • Discover how RWD can be beneficial to optimizing the patient experience


Naomi Litchfield
Patient Advocacy Manager
Bionical Emas

Graham Sidorowicz
Vice President, Business Development, Early Access Programs
Bionical Emas

View More Details +

Patient Pavilion – Optimising the Journey and Continuing the Conversation
4pm CEST / 3pm BST / 10am EDT

  • Prepare to advocate for patient access while understanding and adhering to the practical aspects of enrolling in managed access programmes
  • Strive to increase education and awareness for patients with critical conditions while communicating the opportunities accelerated pathways can provide
  • Effectively advocate and serve as a liaison to provide tangible improvements to meeting patient needs


Theodora Weisz
Senior Director, Public Affairs and Patient Engagement – Europe
Akcea Therapeutics

Mimi Choon-Quinones MBA, Ph.D
Founder and Board Chairman
Partners for Patients (PfP.NGO)

View More Details +

Explore Innovative Models for Managed Access Programme Design and Learn to Operationalise Internally
5pm CEST / 4pm BST / 11am EDT

  • Delve into how companies address the setup of a managed access programme and what components are essential to a successful deployment
  • Investigate key considerations for stakeholder buy-in to ultimately lead to a successful company-wide roll-out of early access programmes
  • Map out the responsibilities from all parties involved to ensure smooth delivery to patients in need


Diana Schuhbauer
Community of Practice Leader, Pre-Approval Access/Compassionate Use, Global Product Development Medical Affairs

Ramona Reichenbach
Head, Managed Access Center of Excellence, Global Drug Development – Chief Medical Office

View More Details +

REGISTER NOW – Please select the webcast(s) you wish to attend and enter your contact details

Day 1

Day 2

Day 3