Regulatory Express
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Updates on GCP Q&A, Remote Pharmacovigilance Inspections, from Heal Authority, Certificates of Confidentiality, etc.. ...
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In the lovely season of autumn, we’d like to share some updates on Data integrity, Risk evaluation and mitigation, Remote inspection, ……. ...
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In Q2 of 2020, we’d like to share some updates/suggestions on Decentralized Clinical Trials, Inspection Hosting, Electronic Systems and Vendor Contracts, and PSP. For a better understanding, recommend to read full articles via website at the end. ...
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Focusing COVID-19, a summary of guides issued by MHRA, EMA and FDA. ...
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新冠疫情下的临床试验建议_来自MHRA ...
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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. ...