Clinical Development of Gene Therapies: The First Three Decades and Counting von Lapteva, Larissa, Purohit-Sheth, Tejashri, Serabian, Mercedes, Puri, Raj K.

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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective von Galli, Maria Cristina, Serabian, Mercedes

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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective von Galli, Maria Cristina, Serabian, Mercedes

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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective von Salmikangas, Paula, Schuessler-Lenz, Martina, Ruiz, Sol, Celis, Patrick, Reischl, Ilona, Menezes-Ferreira, Margarida, Flory, Egbert, Renner, Matthias, Ferry, Nicolas

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Biodistribution studies: understanding international expectations von Huang, Ying, Havert, Mike, Gavin, Denise, Serabian, Mercedes, Ong, Lee Lee, McIntyre, Maritza C, Ferry, Nicolas, Kume, Akihiro, Petrin, Dino, Fu, Ying-Hsien, Marti, Andreas, Oliveira, Fabricio, Pavittranon, Sumol, Shin, Won

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Regulatory Frameworks for Gene and Cell Therapies in Japan von Maeda, Daisuke, Yamaguchi, Teruhide, Ishizuka, Takami, Hirata, Masakazu, Takekita, Kazuhiro, Sato, Daisaku

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United States Food and Drug Administration Regulation of Gene and Cell Therapies von Bailey, Alexander M., Arcidiacono, Judith, Benton, Kimberly A., Taraporewala, Zenobia, Winitsky, Steve

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The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety von O’Reilly, Marina, Jambou, Robert, Rosenthal, Eugene, Montgomery, Maureen, Hassani, Morad, Gargiulo, Linda, Corrigan-Curay, Jacqueline

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Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea von Choi, Minjoung, Han, Euiri, Lee, Sunmi, Kim, Taegyun, Shin, Won

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Regulatory Oversight of Cell and Gene Therapy Products in Canada von Ridgway, Anthony, Agbanyo, Francisca, Wang, Jian, Rosu-Myles, Michael

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Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany von Renner, Matthias, Anliker, Brigitte, Sanzenbacher, Ralf, Schuele, Silke

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Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products von Lucas-Samuel, Sophie, Ferry, Nicolas, Trouvin, Jean-Hugues

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The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built von de Freitas, Daniel Roberto Coradi

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Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore von Goh, Choon Wee, Kellathur, Srinivasan N., Ong, Lee Lee, Wu, Xiaofeng

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Regulation of Cell and Gene Therapy Medicinal Products in Taiwan von Lin, Yi-Chu, Wang, Po-Yu, Tsai, Shih-Chih, Lin, Chien-Liang, Tai, Hsuen-Yung, Lo, Chi-Fang, Wu, Shiow-Ing, Chiang, Yu-Mei, Liu, Li-Ling

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Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland von Marti, Andreas

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Safety Assessment of Biotechnology-Derived Pharmaceuticals: ICH and Beyond von Serabian, Mercedes A., Pilaro, Anne M.

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Preclinical Development Strategies for Novel Gene Therapeutic Products von Pilaro, Anne M., Serabian, Mercedes A.

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IPRF Reflection Paper on Biodistribution von Havert, Mike, Huang, Ying, Nemec, Martin, Palomäki, Tiina, Celis, Patrick, Marti, Andreas, Petrin, Dino, Serabian, Mercedes, Hirata, Masakazu

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L-Proline transport by isolated renal tubules from newborn and adult rats von Hwang, S M, Serabian, M A, Roth, K S, Segal, S

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