2-day In-person Seminar on Human Subjects Research Seminar: Current Regulations under FDA and HIPAA at San Diego, CA

Event Details

Time: June 4, 2015 at 9am to June 5, 2015 at 6pm
Location: San Diego, CA
Street: 1646 Front Street, San Diego, California, 92101, USA
City/Town: San Diego
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Mar 10, 2015

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Event Description

Overview:

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. Current examples will be used and the audience will be invited to share their experiences and information.

Agenda

Day One

Lecture 1: The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research
Lecture 2: Current Federal Regulations and Agencies involved in Human Research
Lecture 3: Selection and Recruitment of Research Subjects
Lecture 4: Informed Consent in Clinical Trials
Lecture 5: Confidentiality of Clinical Trial Information
Lecture 6: The Investigator
Lecture 7: Research Protocols

Day Two:

Lecture 8: Multisite, Community and Collaborative Studies
Lecture 9: The Institutional Review Board
Lecture 10: Patient Safety in Clinical Trials Research
Lecture 11: Research under the Food, Drug & Cosmetic Act
Lecture 12: International Research
Lecture 13: Compliance and Human Research
Lecture 14: Accreditation and Risk Management in Clinical Trials

Instructor Profile:

Sarah Fowler-Dixon 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.

Location: San Diego, CA Date: June 4th & 5th, 2015 Time: 9 AM to 6 PM EDT

Venue: DoubleTree by Hilton Hotel San Diego Downtown

Venue Address: 1646 Front Street, San Diego, California, 92101, USA

Price: $1,295.00
(Seminar for One Delegate)

From May 01 to June 02, Regular Price: $1,495.00

Contact Details:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone: 1-800-447-9407

Fax: 302-288-6884