Featuring

Expanded Access Programmes Global Congress 2022 Europe

Strategies from planning an application to approval and implementation

Days
Hours
Minutes
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1st - 2nd March 2022 - 2 Day Conference
Hilton London Kensington Hotel, London, UK

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Exhibit & Sponsor Opportunities
Venue

Hilton London Kensington

Address

179-199 Holland Park Ave, London W11 4UL, United Kingdom

Phone

+44(0) 207 193 3485

Global Congress 2022 Europe

Expanded Access Programmes

Expanded Access also known by other terms such as compassionate use, early access, managed access, named-patient access, or pre-approval access is a potential pathway for a patient with an immediately life-threatening illness or severely debilitating disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) before they are reviewed and approved by a regulatory authority.

When it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek special access to investigational medicine outside of the clinical trial setting. As investigational drugs have not yet received regulatory approval, it is very important to remember that their potential risks and benefits are not yet established. In general the person and his or her doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit.

The two-day Congress will provide an interactive, cutting edge and comprehensive discussion and
networking format led by key expert speakers with intimate knowledge in the industry. Gain
practical strategies and best practices on challenges, innovations, technologies and concepts in
obtaining the much-needed access to these therapies for life-changing treatment.

We look forward to welcoming you at the Congress!

Read Full Introduction
Insights & Attendees

Featuring Key Industry Experts

Ramona Reichenbach

Head of Managed Access Center of Excellence, Novartis

Pascal King

Market Access Lead, International and Partner Markets, Jazz Pharmaceuticals

Nicola Gillott

Head of Expanded Access, Amryt Pharma plc

Graham Sidorowicz

Senior Vice President, Business Development, Bionical Emas

All Expert Speakers

From a patient advocacy organization perspective, was a very informative meeting. Learned a lot from presentations and networking that will inform how we can add value to the advocacy-patient-drug developer dialogue.

Dr. Nadine Tutton

Scientific Director, Research, Association for Frontotemporal Degeneration

I was very impressed with the format, the content was interesting and well done. I felt I learned a lot and was glad to be able to attend.

Senior Director

Business Development at Pharm-Olam, LLC

View Conference Agenda

EXPANDED ACCESS PROGRAMMES

SPONSORS

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Co-located with

The Expanded Access Programmes congress will be Co-located with the RWE, Market Access, Pricing & Reimbursement Congress. 

Joint Networking at the Exhibit area.

Take advantage of networking with attendees and participants with receptive mindsets, from both events.  

To find out about the range of branding, Exhibit, and Sponsorship Options, get in touch. 

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Expanded Access also known by other terms such as compassionate use, early access, managed access, named-patient access, or pre-approval access is a potential pathway for a patient with an immediately life-threatening illness or severely debilitating disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) before they are reviewed and approved by a regulatory authority. When it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek special access to investigational medicine outside of the clinical trial setting. As investigational drugs have not yet received regulatory approval, it is very important to remember that their potential risks and benefits are not yet established. In general the person and his or her doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit.

With patients thoroughly becoming knowledgeable, Pharmaceutical companies are bound to receive unsought request. However, there are challenges and obstacles such as diverse regulatory landscape, logistical differences, and complexities from planning an application to approval and implementation. Sponsors need to plan carefully before undertaking an Expanded Access Programme so that they have the resources, processes, and tools in place to support the inevitable demand.

The two-day Congress will provide an interactive, cutting edge and comprehensive discussion and networking format led by key expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts in obtaining the much-needed access to these therapies for life-changing treatment.

We look forward to welcoming you at the congress!

Jocelyn Raguindin
Jocelyn Raguindin

Jocelyn is Conference Director at Paradigm Global Events (PGE). She has over 15+ years experience in organizing pharma-industry conferences and has been at the helm of every PGE conference since 2013. Jocelyn is based in London, UK.

Gain Latest Insights on:

  • The current compassionate use, or expanded access-related mechanisms
  • The benefits and issues surrounding expanded access programme
  • Understanding the varying regulatory landscape, policies and guidelines to ensure a smooth execution of the programme
  • Criteria that must be met to authorize expanded access use, requirements for expanded access submissions
  • Understanding operational complexities, best practices and strategies in running a global EAP
  • Successfully navigating logistical intricacies
  • Incorporating patient voice from early planning to ensure a patient-centric access programme
  • Engaging representatives from all stakeholder groups to understand their perspective and expectations of the programme

Who Should Attend?

  • This Congress will provide information to pharmaceutical and biotech companies, researchers, physicians, institutional review boards (IRBs), patient organisations and advocates and regulatory agencies about the implementation of expanded access to investigational drugs.
  • Network with representatives involved in the following areas:
  • Expanded Access
  • Managed Access
  • Early Access
  • Market Access
  • Medical Affairs
  • Regulatory Affairs and Policy
  • Patient Support and Patient Engagement
  • Corporate Development
  • RWE, and Data Management
  • Quality and Compliance
  • Clinical Development
  • Programme Management
  • Supply Chain Management
  • Patient Access
  • Clinical Research
  • Sourcing Logistics
  • Consulting

Ramona Reichenbach

Head of Managed Access Center of Excellence, Novartis

Pascal King

Market Access Lead, International and Partner Markets, Jazz Pharmaceuticals

Nicola Gillott

Head of Expanded Access, Amryt Pharma plc

Graham Sidorowicz

Senior Vice President, Business Development, Bionical Emas

Graham is an experienced senior leader with extensive experience in commercial, market access and medical functions working in small and large pharmaceutical organizations. He has worked implementing EAPs, both for pharmaceutical companies directly and through a provider organization.  During his time working in Medical Affairs, Graham led multiple Real-World Data collection projects and has published data on prospective observational studies and a global registry.