Committee for Advanced Therapies (CAT) Presented by Kieran Been CAT - PowerPoint PPT Presentation

Mar 19, 2023 •9 likes •79 views

Committee for Advanced Therapies (CAT) Presented by Kieran Been CAT member An agency of the European Union Committee for advanced therapies EMAs scientific committee for the evaluation of advanced therapy medicinal products (ATMPs)

Committee for Advanced Therapies (CAT) Presented by Kieran Been – CAT member An agency of the European Union
Committee for advanced therapies • EMA’s scientific committee for the evaluation of advanced therapy medicinal products (ATMPs) Regulation (EC) No 1394/2007 • Provision of scientific recommendations on ATMP classification • Contribution to early discussions with developers • Contribution to scientific advice for ATMPs via ITF consultations • Preparation of scientific guidelines in the fields of gene- and cell- therapy and tissue-engineered products • Scientific evaluation of quality and non-clinical data for certification procedures • Leads discussions among national EU authorities and engages with global regulatory authorities on international standardisation discussions.
Advanced Therapeutic Medicinal Products
Advanced Therapeutic Medicinal Products
CAT workplan 2017/ 18 • Revision and development of ATMP specific guidelines • Reflection on the Benefit-Risk assessment of ATMPs • Reflection on the use of Registry data for the initial evaluation of ATMPs and during the post-authorisation phase. • Scientific and Regulatory considerations on gene editing technologies • Considerations on novel scientific and regulatory approaches for making ATMPs more readily available to patients • Addressing the Environmental Risk assessment of ATMPs containing genetically modified organisms (GMO) / genetically modified micro- organisms (GMM) • Setting up of an ad hoc COMP-CAT working group
Expert meetings
Thank you for your attention European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 6000 Facsim ile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s

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