- Comparison of Expedited Reporting System for Investigational Drugs in the U .S., EU and South Korea
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Cha JW, Rhee HE, Park SJ, Kim S, Cho HK, Lee JE, Lee B, Shim DY, Shin JY
- KMID: 2534669
- J Pharmacoepidemiol Risk Manage.
- 2022 Mar;14(1):11-18.
- doi: 10.56142/2022.14.1.11
As the number of clinical trials conducted worldwide continues to increase, the management of safety information of investigational medicinal products used during clinical trials has become ever more important. Individual... -
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- Comparison of Postmarket Surveillance Strategies of Implantable Medical Devices in the United States, European Union, and South Korea
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Cho Yo, Lee JYe, Shim DaYo, Park SJ, Rhee HE, Sung HG, Kim HJ, Choi NK, Song HJ, K im JA, Park Sm, Shin JY
- KMID: 2534648
- J Pharmacoepidemiol Risk Manage.
- 2021 Sep;13(2):45-54.
- doi: 10.56142/2021.13.2.45
The biomedical industry is making rapid progresses like never before, and the number of adverse events caused by implantable medical devices is also increasing. As such, there is an ever-growing... -
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- A survey for Management of Drug Safety Evaluation System for Investigational Product
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Lee BM, Park SJ, Shim DY, Rhee HE, Lee JE, Kim SH, Cho HK, Shin JY
- KMID: 2517304
- Korean J Clin Pharm.
- 2021 Mar;31(1):53-60.
- doi: 10.24304/kjcp.2021.31.1.53
Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of... -
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