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

Regulatory and Development Approaches to Research for In Vitro Diagnostics vs. Other Medical Devices - The Same or Different?

Over the next 4 years FDA will be phasing out enforcement discretion for Laboratory Developed Tests (LDTs). These tests will be regulated as in Vitro Diagnostic (IVD) medical devices subject to FDA risk classification and premarket requirements for clearance/approval. Likely, there will be an increase in IVD pivotal clinical investigations. 611

Presenter: Wendy Schroeder, BSN, CCRC, CRCP, RN, Principal Strategy Consultant, NAMSA

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