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 Bejot Senior Medical Director

Jean-Luc Béjot, MD, MBA, 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).

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Carole Jones, B.Sc., M.B.A, Director, Market Access

Carole has specialized in the field of Market Access and has an extensive track record of working directly with NICE and NIHR on Health Technology Assessments and policy development in the UK. Carole has close working relationships with several Clinical Commissioning Groups in England, G-BA, HAS and the Centers for Medicare & Medicaid Services in the U.S. which provides an intimate perspective of the changing customer and the future implications for the commissioning of pharmaceutical products. Carole works closely with our clients to ensure an aligned and integrated clinical program and commercialization strategy.

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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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