"The Product is the Process – Is it?" Manufacturing and Translation of ATMPs and Tissue & Cell-Based Products
An event held in cooperation with the Paul-Ehrlich-Institut; the Biotechnologieverbund Berlin-Brandenburg e.V. (BBB); the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG); the German Stem Cell Network (GSCN); HealthCapital – Healthcare Industries Cluster Berlin-Brandenburg; and Berlin Partner.
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Location
Investitionsbank des Landes Brandenburg, Babelsberger Straße 21, 14473 Potsdam
Organiser
bbb e.V., Paul-Ehrlich-Institut, German ZLG, GSCN, HealthCapital
Program
The conference program highlights current developments in cell and gene therapy. These developments range from innovative therapeutic approaches, such as the replacement of beta cells in diabetes patients and new cancer therapies with tumour-infiltrating lymphocytes, to the first authorised externally applicable gene therapy for the rare skin disease dystrophic epidermolysis bullosa. Regulatory aspects will also be addressed, such as the implementation of the EU Regulation on Substances of Human Origin (SoHO) in Germany, the decentralised production of advanced therapy medicinal products (ATMPs), and compliance with quality standards directly at the treatment location. Discussions will also focus on the different authorisation paths in Europe and the USA and new, rapid microbiological test procedures to ensure product safety.
Moderation
Dr Ralf Sanzenbacher, Haematology, Cell and Gene Therapy Division at the Paul-Ehrlich-Institut
Important note: The conference language is English. If necessary, individual questions or discussions can take place in German.
Participation fee: €240.00
A 50% reduced participation fee applies for representatives of public authorities. Please enter your public authority affiliation in the "Remarks" (Anmerkungen) field when registering.
The participation fee for students is €40.00. Please enter your matriculation number in the "Remarks" (Anmerkungen) field when registering.