16th Annual Device Research & Regulatory Conference is organized by the Society of Clinical Research Associates (SOCRA) and will be held from Apr 27 - 28, 2023 at Embassy Suites by Hilton Scottsdale Resort, Scottsdale, Arizona, United States of America.
This annual medical device conference provides attendees with the main program preceded by a half-day device basics workshop. The entire program features experts presenting topics regarding medical device design and development, clinical trial activities, data analysis, quality, and regulatory process, and post-market management.
Attendees include the following roles and responsibilities:
• Clinical Research Professionals (e.g., Principle Investigators, Clinical Research Associates, Clinical Research Coordinators)
• Government, University, Industry, and Support Organization Representatives
• Quality, Regulatory, Research and Development, Engineering, and Human Factors
• Medical Device Designers/Developers
• Medical Device Startup Companies
• Medical Device Vendors, Service Providers
• Clinical Research Organizations
• Anyone interested in learning more about medical device research and the regulatory process
The pre-conference half-day workshop is designed to provide a comprehensive medical device regulatory overview and is a fundamental precursor to the Main Program. Topics include:
• Introduction to the Medical Device Regulatory Framework
• Navigating the 510(k) Pathway
• Building Quality into Clinical Studies - Roles and Responsibilities of Sponsor-Investigators
Day 1 Presentations:
• Keynote: Direct Sponsor Involvement in Clinical Trial Recruitment and Other Trial Activities
• The Ethics and Regulations of Medical Device Research: Treating a Patient or Experimenting on a Research Subject?
• Medical Device Event Reporting
• Lessons Learned: De Novo Classification Pathway
• FDA’s Digital Health Centers of Excellence Program (DHCoE) – Overview of Resources
• Speaker Panel
Day 2 Presentations:
• Keynote: Improving Regulatory Processes through Collaboration
• Utilization of Real World Evidence in Cardiac Lead Post-Approval Studies
• Product Development Process Informs Clinical Trial Design
• Medical Device Industry Trends – 2022 and Beyond
• Cultural Considerations in Global Clinical Trials Management
• Speaker Panel
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
• Discuss FDA medical device regulations, including risk categorization and device classifications.
• Understand risk categories of IDE studies
• Examine roles and responsibilities of Sponsor-Investigators
• Review FDA marketing applications for medical device
Learning Objectives: Main Conference
The participant will:
• Distinguish between allowable and unallowable sponsor activities that put sponsor staff in direct contact with clinical trial participants.
• Identify and address ethical and regulatory considerations in medical device research.
• Understand medical device event reporting regulations and guidelines.
• Discuss regulations for medical device export/import.
• Examine the FDA De Novo Classification Pathway for novel medical devices.
• Describe the Digital Health Centers of Excellence (DHCoE) Program, identify resources available locate Digital Health Software Precertification Information in support of digital health evolution and adoption.
• Discuss ways to break down barriers to innovation and find pathways to FDA approval.
• Examine the application of real-world data to fulfill regulatory post-approval requirements.
• Determine the logistical and regulatory considerations for utilizing real-world data compared to prospective clinical studies.
• Discuss the FDA’s investigational device exemption process.
• Understand design controls and design history files and how the design & development process can be used to enhance clinical trial execution.
• Investigate the critical trends driving future strategies, commercial models, operations, and technologies of the medical device industry.
• Comprehend clinical study cultural aspects and recommendations for implementation.
• Discuss the impact on patient access and compare the standard of care versus clinical trial options for cost savings to patients and hospitals.
• Participate in speaker panel discussions.
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