SOCRA 2024 Annual Conference Program Book - Flipbook - Page 25
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I
Location: Paradise Event Center Foyer
Chrissy Cochran, PhD
Time: 1:15 to 2:00
ID Code: 709
Tendencias en el Diseño de Ensayos Clínicos
de Fase I
Presentador: Ignacio Garrido-Laguna, PhD, MD
Time: 1:15 to 2:00
ID Code: 609
FDAAA 801 and Final Rule (42 CFR Part 11)
ClinicalTrials.gov
Presenter: Susan Hmwe, PhD, MS, MBBS, CCRP
Time: 2:05 to 2:50
ID Code: 611
Regulatory and Development Approaches to
Research for In Vitro Diagnostics vs. Other
Medical Devices—The Same or Di昀昀erent?
Presenter: Wendy Schroeder, BSN, CCRC/PM,
CRCP
Time: 1:15 to 2:00
ID Code: 509
Time to Break Free from Hidden Obstacles and
Deliver a Successful Project
Presenter: Takisha Adair, MBA, CCRP
Time: 2:05 to 2:50
ID Code: 511
Advocating for Project Management within
Small/Medium Biotech/Pharma
Presenter: Natalie Hecht, BS, PMP, CCRP
Time: 2:05 to 2:50
ID Code: 711
Responsabilidades del Investigador Principal
Presentador: Jorge Cruz Gonzalez, MD
Moderator: Abby Statler, PhD, MPH, MA, CCRP
Moderator: Erida Castro-Rivas, MD, MS
Moderator: Susan Hmwe, MBBS, MS, PhD, CCRP
Moderator: Casey Jackson, MS, CCRP
Time: 2:05 to 2:50
ID Code: 811
Monitoring Sponsor-Investigator Protocols:
Lessons Learned from FDA Inspections
Presenter: Abby Statler, PhD, MPH, MA, CCRP
Time: 1:15 to 2:00
ID Code: 809
Cinderella the New CRA and Magical Tips from
the Fairy
Presenter: Tammy Neseth, MA, CCRP
Track 8 – Monitoring
Location: Ballroom G
Track 7 – Spanish / Español
Location: Pavilion 9
Location: Pavilion 11
Track 6 – Regulatory
Location: Pavilion 10
Time: 2:05 to 2:50
ID Code: 411
Medical Misinformation in the Media and the
Challenges It Causes in Patient Treatment and
Clinical Trials
Presenter: Peter Horvath, PhD, CCRP
Time: 1:15 to 2:00
ID Code: 409
Racial and Ethnic Disparity in Clinical Trial
Enrollment: How to Quantify the Problem and
Implement Tangible Solutions to Solve It
Presenter: Veronica Fitzpatrick, DrPH, MPH, BS
Moderator: Allie Mossing, MS, CCRP
Track 5 – Project Management
Time: 2:05 to 2:50
ID Code: 111
Pharmacology and Safety in Oncology Clinical
Trials
Presenter: Jeannie Farnsworth, MS, BS, MRQA,
CCRP
Time: 1:15 to 2:00
ID Code: 309
Patient Engagement in Orphan Drug Research
Presenter: Nahya Awada, PhD, MSCR, CCRP
Time: 2:05 to 2:50
ID Code: 311
Time: 2:05 to 2:50
ID Code: 211
The Importance of Engaging Young People in
Medical Device Clinical Evidence Needs with
Research
MDD to MDR Transition
Presenter: Lorraine Hodsdon, BSc, MSc, RN
Presenter: Mary Sophy Yohannan, MBBS, CCRC
Time: 1:15 to 2:00
ID Code: 209
How Decentralized Clinical Trials Can Facilitate
Trials Involving Medical Devices
Presenter: Kyle Faget, JD, AB
Moderator: Catherine Hudson, MPH, CCRC, CCRP
Moderator: Kathi Durdon, MA, CCRP
Moderator: Susanna Sellmann, BSC, MRT
Time: 1:15 to 2:00
ID Code: 109
Adverse Events: Use of the Common
Terminology Criteria for Adverse Events
(CTCAE) and Documentation Best Practices
Presenter: Rachel Kingsford, MS, CCRP
Track 3 – Patient Engagement
Location: Pavilion 3
Track 2 – Device Research
Location: Pavilion 1
Track 4 – Enrollment / ICF
Location: Pavilion 4
ID Code: 004
Julie Kaneshiro, MA
Location: Paradise Event Center South (Exhibit Space)
ID Code: 003
Ignacio Garrido-Laguna, MD, PhD, MD, MBA
Track 1 – Oncology
Location: Pavilion 6
I
Research Protections and HHS/OHRP Initiatives
11:15 to 12:00
Luncheon
ID Code 001
ID Code 002
Jessica L. Rowe, MA, MS, CIP, CCRP and Laura Holtz, MS, PMP, CCRP
Location: Paradise Event Center South (Exhibit Space)
Trends in Phase I Clinical Trial Design
I
10:30 to 11:15
10:00 - 10:30 AM Morning Break
Welcome and Introduction
FDA Initiatives
9:15 to 10:00
12:00 - 1:15 PM
Friday Morning + Afternoon, September 27, 2024
Moderator: Laura Holtz, MS, PMP, CCRP I Location: Paradise Event Center North
8:30 to 9:15
I
Continental Breakfast
Opening Plenary Session
8:00 AM - 8:30 AM
SCHEDULE-AT-A-GLANCE
