2024 Annual Conference Brochure - Flipbook - Page 13
FRIDAY, SEPTEMBER 27, 2024
BREAKOUT SESSIONS
TRACK 5: PROJECT MANAGEMENT
TRACK 6: REGULATORY / LEGAL
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
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: 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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SOCRA ANNUAL CONFERENCE BROCHURE
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
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