Training course on Advanced Therapy Medicinal Products (ATMPs)

Pharmaceutical regulatory landscape is always changing, evolving, and become more complex every year. 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 and guideline that support the development of Advanced Therapy Medicinal Products (ATMPs) and the specification to consider when building the common technical document and marketing authorisation procedures of ATMPs.

This course will go through all the procedures that Regulatory Agencies make available to the manufacturers to help and support the development of their products, with special attention to these critical points that can be more problematic when brining and advanced therapy medicinal product to the patients.

This course will provide relevant advice to professionals who want to begin or progress in the field of Regulatory Affairs, or for those working in Scientific areas related to Advanced Therapy Medicinal Products that want to know more or get involved in the development process of these products. Such as:

• ATMP Manufacturers
• CMC Development
• Process Development
• Clinical Research specialist
• QC and Stability
• Laboratory Managers
• Regulatory Affairs Department