Expanded Access Programmes Global Congress 2021 Europe
Strategies from planning an application to approval and implementation
7th - 8th October 2021 - 2 Day Conference
Hilton London Kensington
179-199 Holland Park Ave, London W11 4UL, United Kingdom
+44(0) 207 193 3485
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.
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!
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.
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.
Business Development at Pharm-Olam, LLC
EXPANDED ACCESS PROGRAMMES
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.