足不出户，掌上学习FDA法规及注册事务！

原文始发于微信公众号（药时代）：足不出户，掌上学习FDA法规及注册事务！

S1C1:

https://class.drugtimes.cn/detail/v_5d8a4dd2a8d07_145ZPVLk/3

S1C2:

处方药产品提交IND

Prescription Drug Product Submissions – IND

https://class.drugtimes.cn/detail/v_5d8b07f9cafac_Cbv7RS3q/3

S1C3:

处方药产品提交NDA

Prescription Drug Product Submissions – NDA

https://class.drugtimes.cn/detail/v_5dba6f6e85372_Qhr7ztqs/3

S1C4:

药品提交：eCTD模块3

Drug Product Submissions – eCTD Module 3

https://class.drugtimes.cn/detail/v_5dba758642d5f_pMT1CBMl/3

S1C5:

伦理、专利、老药新用、仿制药

Ethics, Patents, Repurposing, Generics

https://class.drugtimes.cn/detail/v_5dba757c49c43_ejfqb2Iq/3

https://class.drugtimes.cn/detail/v_5dba7809cf732_6nPk5UqK/3

S2C1:

非临床药物测试

Nonclinical Drug Testing

https://class.drugtimes.cn/detail/v_5ddceff53edce_4t01t4Kk/3

S2C2:

良好实验室规范（GLP）的应用

Application of Good Laboratory Practices (GLPs)

https://class.drugtimes.cn/detail/v_5ddcf509f2bd2_ykzIiFBq/3

S2C3:

药品临床试验

Clinical Trials of Drug Products

https://class.drugtimes.cn/detail/v_5ddcf797db3a4_vdJjfGxC/3

S2C4:

良好临床规范（GCP）

Good Clinical Practices (GCPs)

https://class.drugtimes.cn/detail/v_5ddcfc33cd140_ChNILH6o/3

S2C5:

肿瘤药物临床试验

Oncology Clinical Trials

https://class.drugtimes.cn/detail/v_5ddcfdd9b89b6_v2cudYm8/3

S2C6:

临床试验统计学

Clinical Trial Statistics

https://class.drugtimes.cn/detail/v_5ddcfe2ea6a45_lkr3fMHK/3

S2C7:

化学、生产及控制（CMC）

Chemistry, Manufacturing and Controls

https://class.drugtimes.cn/detail/v_5ddcfe3235bf0_MhM5jghY/3

S3C1:

质量体系

Quality Systems

https://class.drugtimes.cn/detail/v_5e1d2f2ee8d46_EFObg4yL/3

S3C2:

批准后处方药的提交和合规性

Post-approval Prescription Drug Submissions and Compliance

https://class.drugtimes.cn/detail/v_5e1d3bd6c6664_CPxX4sNH/3

S3C3:

药物标签

Pharmaceutical Labeling

https://class.drugtimes.cn/detail/v_5e1d3bb195646_3Gg4VHrC/3

S3C4:

药物警戒

Pharmacovigilance

https://class.drugtimes.cn/detail/v_5e1d3bc4510c4_ZKJVgAaT/3

S3C5:

风险管理

Risk Management

https://class.drugtimes.cn/detail/v_5e1d556d523d1_XRJB7LYf/3

S3C6:

血液和血液制品

Blood and Blood Products

https://class.drugtimes.cn/detail/v_5e1d53c339955_hIJ4eqb8/3

https://class.drugtimes.cn/detail/v_5e1d547977a24_UIWKNkNg/3

S4C1:

生物药概述

Biologics Overview

https://class.drugtimes.cn/detail/v_5e1d5dcd9956d_no0M5zvN/3

S4C2:

生物药临床试验考虑要素

Biologic Clinical Considerations

https://class.drugtimes.cn/detail/v_5e1d606dbd45e_ZDpymHrC/3

S4C3:

生物类似药

Biosimilars

https://class.drugtimes.cn/detail/v_5e1d6064dd1fd_TRDzNOlR/3

药时代知识宝库 ｜ 一分钱学习FDA药品法规

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