The Investigational New Drug (IND) Workshop
Sponsor(s):
School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Tuesday, June 13, 2017
1:00 pm - 4:00 pm
Kristen Foss, PhD, RAC and Stephanie Pierce, PhD
The Investigational Device Exemption (IDE) Workshop
Sponsor(s):
School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Wednesday, June 14, 2017
9:00 am - 12:00 pm
Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD
Modernizing the Clinical Research System
Sponsor(s):
School of Medicine - Regulatory Affairs, Department of Surgery, Duke Clinical and Translational Science Award (CTSA), Duke Clinical Research Institute (DCRI), and Duke Office of Clinical Research (DOCR)
Monday, October 02, 2017
10:00 am - 11:00 am
UNC Campus, Bondurant G100 or webinar
Rob Califf, MD, MACC
Developing Monitoring Plans for Investigator-Initiated Clinical Trials
Sponsor(s):
School of Medicine - Regulatory Affairs, Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, School of Medicine (SOM), and School of Nursing (SON)
Tuesday, November 14, 2017
11:00 am - 12:00 pm
Sandra SAM Sather, MS, BSN, CCRA, CCRC
Digital Health Rules & Regs: An Overview of FDA Guidelines
Sponsor(s):
Duke Office of Research Initiatives, Duke Clinical and Translational Science Institute (CTSI), and School of Medicine - Regulatory Affairs
Tuesday, March 20, 2018
9:00 am - 10:00 am
Duke Office of Regulatory Affairs and Quality
The Investigational New Drug (IND) Workshop
Sponsor(s):
School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Tuesday, April 10, 2018
1:00 pm - 4:00 pm
Daniel Tonkin, PhD, RAC & Stephanie Pierce, PhD, RAC
The Investigational Device Exemption (IDE) Workshop
Sponsor(s):
School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Wednesday, April 11, 2018
9:00 am - 12:00 pm
Kelly Lindblom, PhD, RAC & Sarah Gemberling, PhD, RAC
