2-day In-person Seminar on Human Subjects Research Seminar: Current Regulations under FDA and HIPAA at San Diego, CA
June 4 - 5, 2015 - San Diego CA USGlobalCompliancepanel
support@globalcompliancepanel.com
Phone:8004479407
Fax: 302-288-6884
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. Areas Covered in the Session: • 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 • Assent vs. consent • Wards of the State • Certificates of confidentiality • Levels of de-identification what they are and how they affect consent • Privacy vs. confidentiality • Study responsibilities: ICH vs. NIH • Drug/Device Accountability • Codes of Conduct • Conflicts of Interest • Reporting responsibilities • Monitoring • Investigator-sponsor responsibilities • Study types • Special concern studies • Standard operating procedures vs. protocol vs. IRB submission • Common compliance issues • Data safety monitoring • Adverse event monitoring and reporting including Serious adverse events and unanticipated problems • Investigational Drug and Device use in clinical trials • Assurances and Agreements (e.g. MOU) • Site Responsibilities • International Ethical Guidelines • Applying ICH to international sites Who Will Benefit: • Principal Investigators / Sub-investigators. • Clinical Research Scientists (PKs, Biostatisticians,) • Safety Nurses • Clinical Research Associates (CRAs) and Coordinators (CRCs) • Recruiting staff • QA / QC auditors and staff • Clinical Research Data managers • Human Research Protection professionals 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 Education Specialist and instructor, Washington University 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. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities. 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) Register now and save $200. (Early Bird) Until April 30, Early Bird Price: $1,295.00 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 support@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/Current-Regulations-under-FDA-and-HIPAA