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Expanded Access Programmes Global Congress 2021 Europe

Days
Hours
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7th - 8th October 2021 - 2 Day Conference
London, UK

Venue

London, UK

Address

TBC

Phone

TBC

Global Congress 2021 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.

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

Gold Sponsor

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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.

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Who Should Attend?

Martine Zimmermann

PharmD, SVP,Head of Global Regulatory Affairs, Alexion Pharma International

Martine Zimmermann is Senior Vice President and Head of Global Regulatory Affairs at Alexion Pharmaceuticals. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board of Caelum Biosciences. She received her PharmD from the University Louis Pasteur in Strasbourg, France, and is based in Zurich, Switzerland.

Igor Rudychev

Head of US Digital, Data, and Innovations, AstraZeneca

Igor Rudychev, PhD, MBA (Booth) has almost 25 years of business experience and for the last 19 years had been specializing in pharmaceutical sales, marketing, and access. Currently, Igor is Head, US Digital, Data, and Innovations with AstraZeneca Oncology. Previously, Igor was leading Global Samples Operations & Access with Pfizer and was leading Global Resource Allocation & Commercial Assessment with Pfizer. Before Pfizer Igor was a Vice President of Pharmaceutical Management Consulting firm in Chicago supporting 18 out of top 20 pharmaceutical clients. Igor has MBA in marketing & finance from University of Chicago, Booth School of Business and PhD in superstring theory & black holes from Texas A&M University.

Robert Donnell

Head of Business Development at Durbin PLC

Robert Donnell has 20 years’ experience in the pharmaceutical sector, working for large blue-chip companies such as Procter & Gamble and AstraZeneca.Robert joined Durbin, one of the world’s leading specialist Comparator and Clinical Trials Supply companies in 2009. He is responsible for global business development across the Durbin Group, including developing relationships and devising strategic partnerships with multinational pharmaceutical and biotechnology companies.Robert has advised several UK Members of Parliament on Healthcare policy and lectures extensively on Global supply issues.

Giovanny Leon

Pricing & Access Regional Director - LatAm & Canada, Novartis

Giovanny is a pharmaceutical executive with intensive experience in a variety of management roles in LatAm and the Novartis Global HQ. He is passionate about improving patient access to medicines in emerging markets, with strong focus on affordability challenges for low and middle-income economies.
He strongly believe in “walk-the-talk” and learning by doing in digital leadership change, that’s why he’s very active in Twitter, LinkedIn and other social media platforms.
He has an MBA and a Master in Marketing and Commercial Management from Universidad Complutense, Madrid and has completed several Management & Leadership programs from University of Cambridge, London Business School, Columbia University, IESA, Universidad de Los Andes, ITAM, ESPM, IAE.