Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)
Im Auftrag der ECA Academy

This workshop 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, all relevant topics directly related to ATMPs will be covered.

Modern systems of regenerative medicines, especially ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of drugs that is becoming increasingly important. With the introduction of several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMP, such products were classified as medicinal products and must therefore comply as such with the EU requirements for medicinal products. Although the biopharmaceutical industry has considerably intensified its activities in this field, many of these products are developed and manufactured at universities, hospitals and in small- and medium-sized companies. These university or medical origins result in special challenges for the respective institutions as well as for the regulatory authorities in fulfilling the compliance requirements for quality, safety and GMP aspects and approval. This is also underlined by commonly occurring operating conditions, e.g. the open manipulation of cells and tissues, which are necessary for obtaining such products on a medical/surgical level or by the short shelf life of the obtained final product.

This results in a whole range of extraordinary requirements:

Building on your education the ECA GMP/GDP certification programmes provide you with the appropriate supplement to acquire this qualification. Simply choose any three courses within the programme according to your professional interest. Your certificate is then valid for two years. To renew it, you can pick any training from the ECA courses and conferences list within that two-years period – allowing you to broaden your knowledge in GMP and GDP compliance.