Скачать или смотреть Jueves Regulatorios - Advanced Therapy Medicinal Products (ATMPs)

Regulatory implementation / enforcement in Advanced Therapy Medicinal Products (ATMPs), which are medicines based on genes, cells or tissues. Within this session we will talk about:

Regulatory framework for ATMPs
Regulatory considerations in the early development phase
Challenges of CMC (Chemistry, Manufacturing and Controls) in the development phase of cell therapy product
Marketing authorization procedure in EU

Speakers:

“Introduction to ATMPs and drug development” Concepción Torrejón More than 11 years’ professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK). 

“Turning adult stem cells into a medicine: the researcher's point of view" Mario Delgado Neuroimmunology of Inflammatory and Autoimmune diseases Group Leader. Alofisel inventor. CSIC licensed Dr. Delgado's invention to Tigenix/Takeda, enabling the company to go on to develop Alofisel.

“CMC challenges in the development of cell therapy products” and “Marketing Autorisation Procedure for ATMPs” Maria A. Revieriego Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.