The Global Guide To Compassionate Use Programs

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.