1Interpretation of guidance on CMC study of in vivo gene therapy productsXU Long-chang, CUI Jing, HE Wu113-1172Interpretation of guidance on CMC study and evaluation of ex vivo genetic manipulation systemLU Jia-qi, LI Qian, HE Wu118-1223Interpretation of guidance on CMC study and evaluation of immune cell therapy productsYANG Fei, HAN Dong-mei, HE Wu123-1274Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for ChinaWANG Jing, HUANG Yun-hong, ZHAO Chen-yang, LU Shuang, GAO Chen-yan128-1335General considerations for viral safety control in continuous manufacturing of recombinant biotechnology productsSAI Wen-bo, HU Ying-ying, WEI Wei134-1376Considerations on pharmaceutical evaluation of perfusion fermentation of recombinant protein biological productsQIU Xiao, SAI Wen-bo, KOU Ya-zhen, WEI Wei138-1427The concerns of CMC research and evaluation of antibody radionuclide conjugates productsWANG Xue, LI Qian, WEI Wei143-1478Considerations on CMC evaluation of human-derived stem cell productsHAN Dong-mei, HE Wu, WEI Wei, WEI Kai-kun148-1539The application of single cell sequencing technology in drug developmentLI Qian, WEI Wei154-15810General considerations on the chemistry, manufacturing, and control research of fermented new drugs for market authorizationZHAO Yi-fei, LIU Zong-ying159-16211CMC requirements for complex generic injectionsZHANG Jun-lin, SHI Yong-ping, NA Xin-zhu, BAI Yu163-16712Considerations on pharmaceutical review for viral safety of blood productsJIA Dong-chen, YU Peng-li, WU Zhou-yi, WEI Wei168-17313Considerations on the establishment of storage conditions of chemical drugsCHEN Miao, REN Lian-jie174-18014Lifecycle management of analytical procedures of biological productsLI Yi-jun, HE Wu, WEI Kai-kun181-18815A brief introduction to the policy and criteria for conditional approval of innovative anti-tumor drugs in ChinaQI Yue-li, ZOU Li-min, JIANG Yong-lin, TANG Ling, DU Yu, ZHAO Bo-yuan, SUN Yan-zhe, XIANG Mei-yi, YANG Zhi-min189-19716The regulatory status of the application of simulation technology in clinical trials and adalimumab case analysisLI Ruo-bing, LI Jian, WANG Jun198-20417A comparative study on the implementation of ICH Q12 management tools in the United States, the European Union and ChinaSUN Guan-nan, ZHANG Ding-heng, YU Fei, ZUO Jin-liang, ZHOU Di, YAN Jiu-xing205-20918Knowledge map study of international pharmacovigilance risk management:Bibliometric analysis based on Web of Science Core CollectionMIN Xiao-qi, YUAN Xiao-liang210-216 