June 2017 .
Regulatory Rapporteur - Voisin Consulting Life Sciences

Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory approval and the final commercial reimbursement needed for an adequate return on investment can also be difficult to obtain. The ATMP development programme should aim to streamline development and avoid known pitfalls in order to produce a viable product that will fulfil its potential in the real-world setting.

This paper discusses an innovative and collaborative approach that needs to be adopted from discovery through all stages of development for ATMPs.

Susan Salako, Regulatory Scientist; Cecile F. Rousseau, Associate Director; François Gianelli, Senior Regulatory Scientist; Carole Jones, Director, Market Access; Valerie Pimpaneau, Vice President, CMC & Quality; Emmanuelle Sabbah-Petrover, Associate Director, Complex Biologics; Gopalan Narayanan, Vice President, Disruptive Biologics.

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