United States Food and Drug Administration regulation of gene and cell therapies / Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, and Steve Winitsky -- The National Institutes of Health oversight of human gene transfer research: enhancing science and safety / Marina O'Reilly, Robert Jambou, Eugene Rosenthal, Maureen Montgomery, Morad Hassani, Linda Gargiulo, and Jacqueline Corrigan-Curay -- Regulatory oversight of cell and gene therapy products in Canada / Anthony Ridgway, Francisca Agbanyo, Jian Wang, and Michael Rosu-Myles -- Overview of the regulatory oversight implemented by the French regulatory authorities for the clinical investigation of gene therapy and cell therapy products / Sophie Lucas-Samuel, Nicolas Ferry, and Jean-Hughes Trouvin -- Regulation of clinical trials with advanced therapy medicinal products in Germany / Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, and Silke Schuele --Marketing regulatory oversight of advanced therapy medicinal products (ATMPs) in Europe: the EMA/CAT perspective / Paula Salmikangas, Martina Schuessler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margaret Menendez-Ferreira, egbert Flory, Matthias Renner, and Nicolas Ferry -- Requriements for clinical trials with gene therapy and transplant products in Switzerland / Andreas Marti -- Regulatory frameworks for gene and cell therapies in Japan / Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, and Daisaku Sato -- Regulatory oversight of gene therapy and cell therapy products in Korea / Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, and Won Shin -- Regulation of cell and gene therapy medicinal products in Taiwan / Yi-Chu Lin, Po-Yu Wang, Shih-Chih Tsai, Chien-Liang Lin, Hsuen-Yung Tai, Chi-Fang Lo, Shiow-Ing Wu, Yu-Mei Chiang, and Li-Ling Liu -- Regulatory oversight of cell- and tissue-based therapeutic products and gene therapy products in Singapore / Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, and Xiaofeng Wu -- The regulatory pathway for advanced cell therapy and gene therapy products in Brazil: a road to be built / Daniel Roberto Coraldi de freitas -- Index.
Series:
American Society of Gene & Cell Therapy 0065-2598 ; 871. American Society of Gene & Cell Therapy
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