GMP for Advanced Therapy Medicinal Products
Im Auftrag deer ECA Academy

This course provides a comprehensive overview of the current regulatory requirements for the development, manufacture and approval of Advanced Therapy Medicinal Products (ATMP). Representatives of regulatory authorities, experts from small-scale and large scale production, QC laboratories and consultants will report on their practical experiences. From the construction of a new production facility to the introduction of a quality system and the final sterility test, the relevant topics directly related to ATMP will be covered.

Advanced therapy medicinal products (ATMP) are an emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. With the adoption of the ATMP regulation EC 1394/2007, ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP. Although pharma industry recently increased their activities to this new area , but the development of these complex products is still focused at universities, hospitals and spin off companies derived thereof (small medium enterprises, SME). This implicates special challenges for compliance these SME with regulatory requirements on marketing authorization and  GMP. With the publishing of the new stand-alone guidance document on the GMP requirements in November 2017, EMA tried to define the expected standards for this special kind of medicinal products.