Webinar on Regulatory Aspects of Advanced Therapy Medicinal Products in the EU
October 19, 2015 - Fremont CA USNetzealous - Compliance4All
support@compliance4all.com
Phone:+1-800-447-9407
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Overview: Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration. The ATMP Regulation 1394/2007 aims to facilitate the patient access to these products and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients. ATMPs are pharmaceuticals with high complexity linked to their development, manufacturing, or administration process. The Regulation addresses the following points: Definition: ATMPs are gene therapy, somatic cell therapy, or tissue-engineered medicinal products. For Marketing Authorizations, the centralized procedure is mandatory. Because of the complexity of ATMPs, a Committee for Advanced Therapies (CAT) has been created. The CAT’s main responsibilities are: The evaluation of MA applications by providing opinions to the Committee for Medicinal Products for Human Use (CHMP); the CHMP may adopt or refuse the CAT opinion. The optional scientific certification of quality and non-clinical data of a proposed ATMP-compound in development. The optional scientific recommendation on ATMP-classification, prior to their clinical development. Why should you Attend: Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury. As this is a new area, early contacts with the regulatory authorities are particularly important. There are a number of procedures available during the development of these products. These procedures are explained in this webinar. Companies can apply to the European Medicines Agency to determine whether a medicine they are developing is an advanced-therapy medicinal product (ATMP). The procedure allows them to receive certification that a medicine, based on genes, cells or tissues, meets the scientific criteria that define ATMPs. The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced-therapy medicinal products (ATMPs) under development by micro, small and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development. Areas Covered in the Session: Introduction Committee for Advanced Therapies (CAT) Stem cells Hospital exemption Relevant guidelines Scientific recommendation on classification Certification procedure Who Will Benefit: Senior management Project Managers Medical writers CRAs and CRCs QA / Compliance personnel Investigators Clinical Research Scientists QA / QC Auditors and Staff Consultants Speaker Profile: Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. Contact Detail: NetZealous LLC DBA Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link: http://bit.ly/1JirnM8