TRAINING COURSE ON ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs)

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Pharmaceutical regulatory landscape is always changing and evolving. Understanding the regulatory environment is vital for the pharmaceutical development of a product, especially for advanced and innovative medicinal products that may lack new guidelines and expertise from the Regulatory Authorities.

This course will review the role and evolution of the most relevant Regulatory Agencies, the different procedures that supports the development of Advanced Therapy Medicinal Products (ATMPs) and the specification to consider when building the common technical document and marketing authorisation.

The course will be held on April 18 and 19 from 10:00 am to 1:00 pm.

WHO SHOULD ATTEND THIS COURSE

This ATMP course is designed and targets a diverse range of professionals with specific expertise in the field that want to know more about. The development process of these products. The course is specifically focus on:

  • ·       ATMP Manufacturers and Commercialization
  • ·       CMC Development
  • ·       Process Development
  • ·       Clinical Research Specialist
  • ·       QC and Stability
  • ·       Laboratory Managers
  • ·       Regulatory Affairs Department
  • ·       Scientists and Researchers
  • ·       Healthcare Professionals
  • ·       Industry Professionals and Entrepreneurs

TRAINER

MARIA REVIRIEGO

Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.More than 20 years’ professional experience across Europe mainly in Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different biopharmaceutical companies and business models. 

She worked as Regulatory Affairs Head in TiGenix (currently Takeda) where among other projects with ATMP, she was actively involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe). 

Since April 2019 she established herself as an independent consultant and has collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs. 

Lecturer in Pharmaceutical Industry Masters.

For more information visit our website.