ERA Consulting USA LLC, Green V Sustainable Center, South San Francisco, CA
09/14/09
‘Advanced Therapy Medicinal Products’, first defined in EU Directive 2003/63/EC, cover gene, somatic cell and human tissue-engineered products. In response to scientific progress a regulatory basis has been developed in the EU, including, for the first time, tissue-engineered products. A dedicated review group, the Committee for Advanced Therapies (CAT) has been instituted at the European Medicines Agency (EMEA) to deal specifically with this class of product. This course will address the regulation of ‘Advanced Therapy Medicinal Products’ in the EU and provide practical advice relating to the CMC, preclinical and clinical development of these products from the European perspective. The opportunities in the European regulatory environment and future trends will also be discussed. For those not familiar with the topic in Europe this will provide a sound overview. For those already working in the field this session would bring the individuals right up to date with recent developments. Topics covered in this seminar include: · The EU regulatory framework for Advanced Therapy Medicinal Products (gene, cell therapy and tissue engineered products) · Opportunities in the EU regulatory landscape, especially for treatment of rare diseases: How can they benefit your Company? · Current and future regulatory guidelines: Latest developments and implications for your company and product portfolio · What are the EU CMC/quality issues/requirements at various stages of development? · Preclinical program: EU regulatory expectations - rational approach · Clinical trials with Advanced Therapy Medicinal Products in the EU This is an exciting half-day workshop for regulatory professionals, project managers, product development team members in the biopharmaceutical industry to gain insight into the regulation of advanced medicinal products from clinic to market.
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