Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior to marketing authorisation and commercial launch (with the assumption that a favourable risk: benefit exists). This paper discusses the possible pathways to an early access programme.
Published on Nov 19th. 2019
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whitepaper by
Emmanuel Prades, M.Sc.
Senior Director, Medical Devices
With over 20 years in Clinical development in diverse areas from pharmaceutical to medical device industry, Emmanuel has broad technical expertise in clinical trial regulations and associated country-specific requirements and has extensive experience in various trial phases, product types, indications, and geographical areas. He has extensive experience in strategic clinical decision meetings with various cross-functional activities for regulatory, safety, quality, and study organization. He also has experience in quality as a clinical QA advisor (audit, SOP writing, Team training).
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