This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners.

Date : 3rd November 2016 to 4th November 2016

Place : United States, Atlanta

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900671SEMINAR

Contact Person:Event Manager

Description:

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners.

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. will be held in Atlanta,United States on date 2016-11-04

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Deadline for abstracts/proposals : 1st November 2016

Keynote Speakers : Sarah Fowler-Dixon Education Specialist and instructor, Washington University Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.

Conference Highlights :• Department of Health and Human Services regulations, 45 CFR 46 • Office for Human Research Protections Guidance • The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814 • HIPAA and HI-Tech • ICH E6 Good Clinical Practices • Coercion vs. undue influence • Recruitment of Research Subjects • Vulnerable populations • Non-English speaking populations • Inclusion of Women and Minorities • Waivers of consent • Waivers of consent vs. waivers of authorization • Ass

Venue :DoubleTree by Hilton Hotel Atlanta Airport, Norman Berry Drive, Atlanta, GA, United States

Check the event website for more details.