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Regulatory Express

Regulatory Express__新冠疫情下的临床试验：来自MHRA, EMA,FDA的指导原则

Focusing COVID-19, a summary of guides issued by MHRA, EMA and FDA. ...

2020-03-30 11:10:02
新冠疫情下临床试验的管理 - 来自MHRA的建议

新冠疫情下的临床试验建议_来自MHRA ...

2020-03-16 12:14:59
Regulatory Express_Q1 2020

6 updates from active regulatory Agencies, hot topics covering Adaptive design clinical trial, Remote Decentralized clinical trial, Signal Management System, RWE/RWD, Data integrity, even Novel Coronavirus. Read following for details. ...

2020-03-13 10:18:38
Regulatory Express_Q4 2019

The last batch of Regulatory Express in 2019, along with warm wishes for 2020. Happy New Year. ...

2019-12-27 16:01:42
Regulatory Express_Q3 2019

Some Regulatory Authority perspective on EHR system、RBM Approaches、COA and so on. Also an interesting analysis of FDA and EMA New Drug Approval Metrics ...

2019-09-25 09:34:41
Regulatory Express_Q2 2019

5 topics are collected from FDA、MHRA、ICH and EMA, ranging from RWE、ICH guidline to RBM. ...

2019-06-24 11:36:14

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