Patient Centricity & Collaboration Global Congress 2021 Europe
8th - 9th November 2021 - 2 Day Conference
Global Congress 2021 Europe
Patient Centricity & Collaboration
Patient Centricity & Collaboration 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.
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