Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective
暫譯: 基因療法與細胞療法產品的法規面向：全球視角

Maria Cristina Galli was co-editor of the first edition.

Dr. Galli holds a University degree in Biological Sciences and a PhD in Molecular Medicine. Her main expertise is in regulatory sciences for translational medicine in the Advanced Therapy Medicinal Products (ATMP) field, supported by scientific education and more than 20 years research experience in experimental oncology, cellular biology, and molecular immunology.

Until her retirement end of 2020, dr. Galli was senior researcher at the Istituto Superiore di Sanità, Roma, Italy. For 25 years she served as quality assessor for gene therapy and biotechnology medicines in national as well as European procedures; at the same time, she was a Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) inspector in the field of gene therapy and biotechnology with special experience in ATMP production and preclinical studies. Dr. Galli was a member of the Committee for Advanced Therapies (CAT) at the European Medicine Agency (EMA) in 2009-2011 and vice-chair/chair of CAT-EMA Gene Therapy Working Party in 2008-2012, in which she participated since its first meeting in early 2000s. Until 2020 she was chair of the ATMP platform in the European infrastructure for translational medicine EATRIS-ERIC, after having been co-chair for 3 years. From 2018 to 2020 she was chair of the Gene Therapy Products Working Party of the European Pharmacopoeia Commission, European Department for the Quality of Medicines, Strasbourg, France, after having served as expert in the previous term (2004-2010) of that working party.

Since 2005 dr. Galli has been regularly invited at international scientific conferences or meetings and has also regularly given classes in master courses at various Italian Universities, on scientific and regulatory aspects of ATMP development and on GMP for ATMP.

Dr. Galli is presently a free-lance consultant in the field of gene and cell therapy development and production.

瑪麗亞·克里斯蒂娜·加利（Maria Cristina Galli）是第一版的共同編輯。

加利博士擁有生物科學的學士學位和分子醫學的博士學位。她的主要專長是轉化醫學的監管科學，特別是在先進療法藥品（Advanced Therapy Medicinal Products, ATMP）領域，並擁有超過20年的實驗腫瘤學、細胞生物學和分子免疫學的研究經驗。

在2020年底退休之前，加利博士是意大利羅馬的國家衛生研究所（Istituto Superiore di Sanità）的高級研究員。她在國內和歐洲程序中擔任基因療法和生物技術藥物的質量評估員長達25年；同時，她也是基因療法和生物技術領域的良好生產規範（Good Manufacturing Practice, GMP）和良好實驗室規範（Good Laboratory Practice, GLP）檢查員，特別專注於ATMP的生產和臨床前研究。加利博士在2009年至2011年間是歐洲藥品管理局（European Medicine Agency, EMA）先進療法委員會（Committee for Advanced Therapies, CAT）的成員，並在2008年至2012年間擔任CAT-EMA基因療法工作小組的副主席/主席，自2000年代初期的第一次會議以來參與該小組。直到2020年，她是歐洲轉化醫學基礎設施EATRIS-ERIC的ATMP平台主席，此前擔任了3年的共同主席。從2018年到2020年，她是法國斯特拉斯堡歐洲藥典委員會（European Pharmacopoeia Commission）基因療法產品工作小組的主席，此前在該工作小組的上一任期（2004-2010）中擔任專家。

自2005年以來，加利博士經常受邀參加國際科學會議或會議，並定期在各個意大利大學的碩士課程中授課，內容涵蓋ATMP開發的科學和監管方面以及ATMP的GMP。

目前，加利博士是一名自由職業顧問，專注於基因和細胞療法的開發與生產。