Regulatory / Legal
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2024 Agenda
Fri., Sept. 27 1:15 to 2:00 Track: Regulatory
FDAAA 801 and Final Rule (42 CFR Part 11) ClinicalTrials.gov
Dr. Hmwe will present how to stay compliant for FDAAA 801, Final Rule 42 CFR Part 11 and NIH Data Dissemination Policy requirements.
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Presenter: Susan Hmwe, PhD, MS, MBBS, CCRP, Manager,Clinical Research Data Quality & Reporting, City of Hope Comprehensive Cancer Center
Fri., Sept. 27 2:05 to 2:50 Track: Regulatory
Data Privacy - A Guide to Understanding GDPR & Privacy In Trials
For companies conducting and supporting clinical trials in the UK & EU, navigating the contractual and operational requirements can be convoluted and seemingly impossible. Ms. McIntosh will walk through the basic steps of understanding and creating realistic programs, security and expectations when navigating the ever-changing privacy regulations. 611
Presenter: Jenifer McIntosh, JD, BS, Shareholder, Data Privacy & Security, Ferguson Braswell Fraser Kubasta, PC
Fri., Sept. 27 3:25 to 4:10 Track: Regulatory
The DEA’s Regulatory Registration of Controlled Schedule I Substances in Clinical Research
The Drug Enforcement Administration (DEA) Schedule I research registration program helps to prevent the diversion of these drugs into the illegal market and helps to ensure that research with Schedule I controlled substances is conducted in a responsible and ethical manner. 613
Presenter: Li Fang, PhD, Drug Science Specialist, Drug Enforcement Administration
Fri., Sept. 27 4: 15 to 5:00 Track: Regulatory
What You Need to Know About Revision 3 of the ICH GCP Guidelines
Dr. Hmwe, Ms. Farnsworth and Ms. Kingsford will provide an introduction to ICH E6 (R3) Guidelines. The 11 principles for clinical research (not 13 from R2) will be discussed as well as key updates from R2 (principles 6 & 7). 615
Presenters: Susan Hmwe, PhD, MS, MBBS, CCRP, Manager,Clinical Research Data Quality & Reporting, City of Hope Comprehensive Cancer Center
Jeannie Farnsworth, MS, BS, MRQA, CCRP, Regional Clinical Scientist, ICON
Rachel Kingsford, MS, CCRP, Senior Clinical Research Manager, Huntsman Cancer Institute