Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective

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.

Maria Cristina Galli 是第一版的共同編輯。

Galli 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（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，Galli 博士是意大利羅馬的國家衛生研究院（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（GMP）和良好實驗室規範（GLP）檢查員，對 ATMP 生產和臨床前研究有特別的經驗。Galli 博士在 2009 至 2011 年期間是歐洲藥品管理局（EMA）先進療法委員會（CAT）的成員，並在 2008 至 2012 年期間擔任 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一直參與該小組。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的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，Galli 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，內容涉及 ATMP 開發的科學和監管方面以及 ATMP 的 GMP。

目前，Galli 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。