THE GLOBAL GUIDE
Finally, there is a single resource you can turn to that will provide the information required to initiate a compassionate use/expanded access program
Compassionate use or expanded access refer to the means for providing unapproved medications for treating patients with serious medical conditions when no other treatments are available. Governments around the world have created provisions for granting access to unlicensed or investigational drugs to patients who have exhausted all available treatment options or have no treatment alternatives in their country. These pathways are grouped under the labels of compassionate use programs (CUP), expanded access programs (EAP), or single named patient programs (NPP).
The Global Guide to Compassionate Use Programs was developed over four years by industry, government, regulatory, operational and pharmacovigilance experts with decades of combined global experience.
This book will help you navigate the complex and often confusing individual country regulations, guidance documents, submission requirements and applications – and clarify the roles and responsibilities of the key parties involved in initiating program requests including manufacturers and innovator-led programs.
Using this comprehensive reference guide will save you valuable time by translating and collating website information from various countries. This compendium includes over 100 of the most common countries, where there is a validated demand for compassionate use/expanded access programs, specific details on the various regulatory pathways including critical weblinks that allow you to immediately access source regulation documents, including those dealing with pharmacovigilance and drug labelling requirements.
Regular updates will be available to address new or revised legislation, providing you with the most up-to-date information and ensuring compliance for stakeholders including sponsors, physicians, pharmacists and independent consultants.
Purchasing access to the resource provides you with immediate access to current content, with regular alerts to updates on a per-country basis.
The Global Guide to Compassionate Use Programs is your one-stop source for all aspects of compassionate use and expanded access
- Saves you vast amounts of time searching websites and interpreting complex and confusing information by compiling it into one source
- Ensures the most current information is available so you can be assured of compliance with applicable laws and regulations
- Provides easily digestible material that can easily be quickly applied to your specific access challenge