Seminar Nr. 15769
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Considering the ongoing development of the new GMP related guideline documents for Advanced Therapy Medicinal Products, this workshop aims to provide an insight view in the discussion and the proposed regulatory adaptions on ATMP with a focus on GMP aspects important for development and manufacturing of Advanced Therapy Medicinal Products. Representatives from authorities, consulting as well as from academia and manufacturers will share their experiences with you and give you the possibility to discuss intensively the challenges for ATMPs.
Advanced therapy medicinal products (ATMP) represent an emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. With adoption of the ATMP regulation EC 1394/2007, all ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP requirements. Pharma industry recently increased their activities to this new area, nevertheless 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 of the different stakeholders with regulatory requirements on GMP.
This course is advisable to people who
On 27 March 2017, the evening before the Workshop, you are cordially invited to a social event at the nh Hotel. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. Starting Time 18.30 h
GMP for ATMP – A Regulatory View