November 2024 SOCRA Source Journal - Journal - Page 99
18th Annual Device Research and GCP Conference
Regulations and Guidelines for Device Clinical Research
APRIL 23 & 24, 2025 | NEWPORT BEACH, CA
*PRECONFERENCE - APRIL 23, 2025 (OPTIONAL)
IN-PERSON
Workshop Registration Fee: $675 (Non-member $750 - includes one year's membership)
Preconference fee - $175
Goal: This DEVICE RESEARCH conference for Clinical Research Professionals will introduce, explain and discuss
concepts and current issues relating to compliance, research development and clinical investigation in the current
regulatory environment. Those new to device research may also elect to participate in the half-day DEVICE BASICS
workshop which will be held the afternoon prior to the main 2-day program.
Objective: This 2-day advanced conference will include experts involved in the research and development of safe
and effective medical devices. Day 1 includes an introduction to the FDA’s regulatory framework for device research,
developing a PMA submission strategy, a 510(k) update, legislative and regulatory developments affecting research,
the Physician Payment Sunshine Act, conducting clinical trials in Asia Paci昀椀c, as well as a device research case study.
Day 2 will include presentations on healthcare trends affecting the medical device industry, issues related to human
factors, the bene昀椀ts of usability testing during the medical device procurement process, and best practices for
sourcing outside clinical development support services. Presenters will also discuss strategies for adding software for
a medical device and writing protocols for trials involving software as a medical device, issues related to developing
a registry, and real-world issues related to medical device research.
Learning Objectives - Pre-Conference Workshop - The participant will be able to:
• Discuss the regulations that govern the administration of
device research including risk categorization and device
classi昀椀cations
• Discuss differences between device and pharmaceutical
clinical research
• Discuss roles and responsibilities of key device research
professionals
• Discuss issues related to CDRH BIMO IRB inspections
• Review the basic concepts related to medical device research
Learning Objectives – Main Conference - The participant will be able to:
• Discuss issues related to the conduct of device
clinical research
• Describe approaches to navigate FDA and manage INDs
and pre-submissions
• Discuss strategies for PMA submissions
• Describe current issues related to 510(k) guidances
• Describe legislative and regulatory development affecting
device clinical research globally
• Discuss how Physician Payment Sunshine Reporting affects
medical device research
• Discuss issues related to conducting clinical trials in
Asia Paci昀椀c
• Describe issues related to IDEs, marketing applications, GCP
and compliance strategies as demonstrated through the use
of a case study
• Discuss issues faced in conducting medical device research
• Describe important healthcare trends and how they may
affect the medical device industry
• Discuss how incorporating human factors and collaboration
design can mitigate challenges in the product development
process
• Describe the bene昀椀ts of usability testing during the medical
device procurement process
• Discuss best practices in sourcing outside clinical
development support services
• Discuss strategies for adding software for a medical device
• Describe strategies for developing successful protocols
involving software as a medical device
• Discuss issues related to developing a registry, obtaining
regulatory approvals and how to properly use a registry in
clinical research
• Discuss real-world issues related to medical device research
SOCRA designates this educational activity for a maximum of 17.5 Continuing Education Credits
for SOCRA CE and Nurse CNE.
SOCRA designates this live activity for a maximum of 17.5 AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
*Device Basics - PreConference Workshop - maximum 4.5 CE Device Regulations - 2 day Conference - maximum 13.0 CE
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series: 900
SOCRA SOURCE © November 2024
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