SOCRA 2024 Annual Conference Program Book - Flipbook - Page 35
FRIDAY, SEPTEMBER 27, 2024
BREAKOUT SESSIONS
TRACK 5: PROJECT MANAGEMENT
PAVILION 11
TRACK 6: REGULATORY / LEGAL
PAVILION 10
Moderator: Casey Jackson, MS, CCRP
Moderator: Susan Hmwe, MBBS, MS, PhD, CCRP
Fri., Sept. 27 1:15 to 2:00 Track: Project Management
Time to Break Free from Hidden Obstacles and Deliver
a Successful Project
Ms. Adair will consider six common pitfalls that must be
avoided when making crucial decisions that could
significantly impact business outcomes. By steering clear
of these psychological traps, we can alleviate stresses
and concerns that arise when making decisions. 509
Presenter: Takisha Adair, MBA, CCRP, Director, Research &
Development
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.
609
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: Project Management
Advocating for Project Management within
Small/Medium Biotech/Pharma
Ms. Hecht provide the audience the confidence to build a
business case for PMO/PM (Project Management
Office/Project Management) tools within a growing
company. 511
Presenter: Natalie Hecht, BS, PMP, CCRP, Clinical Operations
Lead, Immatics
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: Project Management
Clinical Research Scorecard- Performance Metrics
Ms. Hendricks will provide an overview of the creation of
a Clinical Research Scorecard (dashboard). 513
Presenter: Maria Hendricks, MSN, RN, Director, Clinical
Research Operations, Abramson Cancer Center, University of
Pennsylvania
Fri., Sept. 27 4:15 to 5:00 Track: Project Management
Project Management For All Clinical Research
Professionals
Ms. Thompson will discuss what a project is, the purpose
and importance of a project manager, and high level
concepts and methodologies that will help with managing
projects (clinical trials, contracts, IT projects, internal
initiatives, etc.). 515
Presenter: Jess Thompson, MS, BS, CCRC, PMP, Founder, CEO,
Clinical Research Project Management Association
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Fri., Sept. 27 3:25 to 4:10
Track: Regulatory
The DEA9s 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
