Regulatory Challenges

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.

Jean-Luc Béjot, Senior Medical Director Head of Applied Clinical Research

Jean has over 29 years of international experience in clinical development and in medical affairs in the life science industries. His main experience and expertise lie in early stage (phases I and II) clinical development, and he has been exposed at various depth to many steps of the medicinal products life cycle (medicinal chemistry, pre-clinical, clinical, marketing, licensing).

Emmanuel Prades, Director Clinical Operations

Emmanuel has significant experience in the management of international clinical studies (pre, post-market. Device/feature validation, research studies) from protocol writing to report.

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