A Regulatory and Logistical Overview
Even with recent tendencies towards accelerated marketing approval, new treatments do not make it to market fast enough. Moreover, while regulators and developers generally prefer that patients gain access to investigational drugs by participating in clinical trials, patients are not always eligible to take part.
Managed Access Programmes (MAPs), also known as compassionate use, expanded access, medical need or patient assistance programmes, are one solution for early access to investigational products that are gaining traction.
This approach differs significantly from the traditional drug development process and brings with it new regulatory and operational complexities. Without the right knowledge, resources, processes, and tools, clinical teams can be caught off guard by the demands of a MAP.
To help you prepare, ICON is writing a series of whitepapers to serve as a primer on Managed Access Programs. The first will explain how MAPs differ amongst themselves, globally, and from randomised clinical trials; when they are appropriate; how they are regulated around the world; and how to plan for them.
Pre-order your copy of the first MAP whitepaper. Get the insights you need to understand and plan for the regulatory and operational challenges in managed access programs.