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  • stephen gilbride

    SG Researchlnternational President

    讲课时间:0000-00-00 00:00:00

    Stephen Gilbride is currently the President of SG ResearchInternational (SGRI),a GxP Quality Assurance consulting firm based inWyckoff,NJ and with offices Beijing,China.Mr.Gilbride began his career withPfizer in New York in 1990 with increasing levels of leadership andresponsibility.He has extensive global drug development experience,particularlyas it pertains to Good Clinical Practices.Throughout his career,he hassuccessfully influenced the quality organizations he has worked with.He hasmade a positive impact on both small and mid-size biotech companies,championingthe quality environment leading to successful submissions.SGRI wasstarted in 2006.SG Research International(SGRI)has a talent network of seasonedand regionally-based GxP auditors with backgrounds in the Global Pharmaceuticaland Biotech Industries.We are positioned to leverage their broad range ofexperience to reduce risk in clinical trials.All SGRI Auditors are 100% independent.Mr.Gilbride received his bachelor’s degree from ChaminadeUniversity in Honolulu,Hawaii.He was a Research Fellow at the University ofCape Town in South Africa in the late 1980’s.He holds a master’s degree in DrugRegulatory Affairs from the Albert and Marie Schwartz School of Pharmacy(LIU).Hehas presented and published on a number of topics in thepharmaceuticalindustry.

课程介绍

【课程简介】

临床研究监管当局对项目的检查结果,可直接影响该产品是否能顺利批准上市,比如我国CFDA的核查/视察、美国FDA/ICH/EMA的视察等。做好充分的准备,良好的应对视察的整个流程,对检查的通过起着至关重要的作用。本期课程特邀SG研究国际董事长 Stephen Gilbride分享美国FDA视察时需要准备及注意哪些问题,欢迎收看!

【课程大纲】

1. 美国FDA视察简要介绍

2.接受FDA视察前、中、后的准备工作及注意事项

3.美国FDA视察的关注点及视察后续工作

【为您专属】

医疗机构临床研究人员、机构管理人员、质量管人员;申办方/CRO/SMO临床研究相关人员、质量管理人员;第三方稽查公司稽查人员等。

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