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Meeting preview: EAPB's special interest groups will meet in Hannover

Meeting preview: EAPB's special interest groups will meet in Hannover Meeting preview: EAPB’s special interest groups will meet in Hannover In combination with the biotech trade fair Biotechnica the European Association of Pharma Biotechnology – EAPB – holds its next workshops of special interested groups on “Regenerative Medicine” and “Regulatory aspects” on October 4th, 2010. and developers from academia and industry in order to share experiences and handy tips for the process of scientific advice by regulatory agencies and for the development of cell-based products in Europe. Presentations will be about the significance of scientific advice for small enterprises and the dos and don’ts during the process of scientific advice as well as quality standards of stem cell based therapies. sentations and discussion forums. The aim of this workshop is to bring together experts on regulation and experts from academia and industry in order to share experiences and discuss different opinions on two selected current hot topics: “Quality by Design” and “Subvisible Particles”. BTJ-FORUM Regenerative medicine Advanced Therapy Medicinal Products (ATMPs) are tightly regulated by the European Medicines Agency (EMA) with the intention to ensure the safety, efficacy as well as the good quality of the products. A well defined risk evaluation in order to cover the whole development process and not only quality or safety risks should be set-up. For example, tumorigenicity, genome stability, biodistribution are now among the top issues during non-clinical and clinical development and need to be addressed for stem cell-based products early. A key point is hereby an efficient communication with the regulators as early as possible to avoid detours or even worst failures. So the scientific advice became a very powerful tool to find the right way through the jungle of guidelines, reflection papers, regulations and the expectation of the regulators. The aim of this workshop is to bring together experts on regulation About EAPB – The European Association of Pharma Biotechnology The European Association of Pharma Biotechnology (EAPB) is the representative of pharmaceutical biotechnology in Europe and dedicated to the advancement of biotechnology in pharmaceutical sciences, specifically as applied to medicinal drugs, industrial materials, processes, products and their associated issues. As a nonprofit organization EAPB provides a central network linking academia, industry and regulatory bodies. Accordingly its members are professionals from biotechnology and pharmaceutical companies, governmental authorities, academia and scientific organizations. Events organized by EAPB promote collaborations between science and industry in the sector of pharmaceutical biotechnology. Specifically the technology transfer focused Science to Market Conferences intent to enhance the economical output of scientific research and direct them into marketable technologies and biopharmaceutical products. By Dr. Marion Kronabel E-mail: marion.kronabel@eapb.org http://www.eapb.org Regulatory aspects for biopharmaceuticals In contrast to many other sciences, the biopharmaceutical sciences are heavily impacted by national and international regulations so that developers and manufacturers of biopharmaceutical drug substances and drug products need profound knowledge of the current drug regulations in the field as well as of current regulatory opinions. On the other hand, drug regulations must consider what is scientifically feasible and sensible. This balance is achieved the best by frequent exchanges between industry, academia and regulatory bodies. The SIG Regulatory Aspects for Biopharmaceuticals wants to give this exchange room and targets at taking up current hot topics in pre- A detailed program with titles and speakers will be published during July 2010. Registration will be open starting July 2010. Location: Time: Registration fee: 150,– D 50,– D for non-members for existing members of special interest groups Biotechnica, Conference Centre Hannover Messe October 4, 2010, 1:30 – 5:30 pm © 2010 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biotechnology Journal Wiley

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