FDA 101 Flyer - Homepage - CMU - Carnegie Mellon … 101 sERVICES 798 U.S. Department of Health and...

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Wednesday, April 13, 2016 4:30-6 pm Gates 7101 Register: bit.ly/1SC0RBI In this seminar, Dr. Gupta will be sharing her experiences with regulatory agencies, specifically the Food & Drug Administration, to help CMU researchers and entrepreneurs in medical products appreciate the regulatory standards as well as opportunities for expedited development and approval of a well-differentiated product. Current case studies will highlight importance of prospective target profile strategy and FDA alignment. Part of the Inside-Out Commercialization Workshops for Faculty, Postdocs and Senior Graduate Students cmu.edu/cie FDA 101

Transcript of FDA 101 Flyer - Homepage - CMU - Carnegie Mellon … 101 sERVICES 798 U.S. Department of Health and...

Page 1: FDA 101 Flyer - Homepage - CMU - Carnegie Mellon … 101 sERVICES 798 U.S. Department of Health and Human Services Title Microsoft Word - FDA 101 Flyer.docx Created Date 4/1/2016 9:27:37

Wednesday, April 13, 2016 4:30-6 pm

Gates 7101

Register: bit.ly/1SC0RBI In this seminar, Dr. Gupta will be sharing her experiences with regulatory agencies, specifically the Food & Drug Administration, to help CMU researchers and entrepreneurs in medical products appreciate the regulatory standards as well as opportunities for expedited development and approval of a well-differentiated product. Current case studies will highlight importance of prospective target profile strategy and FDA alignment. Part of the Inside-Out Commercialization Workshops for Faculty, Postdocs and Senior Graduate Students

cmu.edu/cie

FDA 101

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FDA 101 Session: Care and Feeding of an Investigational ...ascpmeeting.org/wp-content/uploads/2013/08/SLIDES-TO-USE-FDA-1… · • Clinical Hold order may be issued during the 30-day

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FDA 101 Session: Care and Feeding of an … · •Completes and signs Form FDA 1572 (Statement of the Investigator) –Name/address of the investigator –Education, training, and

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jeffline.jefferson.edujeffline.jefferson.edu/.../tjuh_cne/flyers/flyer.docx · Web viewThomas JeffersonUniversity Hospital is a Magnet® recognized hospital Thomas JeffersonUniversity

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