Device Research & Regulatory Conference: The Premier Conference for Device Professionals
Goal: This annual medical device conference provides attendees with a main program preceded by a half-day device basics workshop. The entire program features experts presenting timely medical device-related research and regulatory topics.
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, 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 regulatory process
The preconference half-day workshop is designed to provide a basic regulatory overview specific to medical device and is a fundamental precursor to the Main Program. Topics include:
- Overview of medical device through terminology
- Device specific regulations and classification
- Good Clinical Practice
- Roles, Responsibilities and Study Monitoring
- Premarket Submissions
Day 1 Presentations:
Devices, Decentralized, and Quality by Design, 3 Pillars to Success
FDA Breakthrough Devices and Safer Technologies Programs
Career Planning: Acquiring Competencies & Champions
GDPR and Other Regulatory Frameworks
FDA’s Digital Health Centers of Excellence Program (DHCoE) – Overview of Resources
Day 2 Presentations:
- The Ethics and Regulation of Medical Device Innovation
- Increasing Female Enrollment in Clinical Studies
- Imagining Failures to Identify Blind Spots in Device Research
- What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule
- Updates to FDA Inspectional Guidances
- CRA Study Startup and Closeout
- Speaker Panel
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
- Discuss FDA medical device terminology as an introduction to the workshop.
- Describe regulations, including risk categorization and device classifications.
- Understand the types of premarket submissions submitted to CDRH as well as best practices and strategies for submissions.
- Examine Good Clinical Practice for medical device as well as the roles and responsibilities key partners in clinical research.
- Review and share medical device study monitoring processes.
- Interactive Q&A
Learning Objectives: Main Conference
The participant will:
- Discern how applying quality by design principles increases participant safety and data quality while supporting trial efficiency.
- Examine the goals of the FDA Breakthrough Devices and Safer Technologies Programs to provide patients and providers with timely access to medical devices.
- Discuss resources for professional development and provide insights for leveraging support in career growth.
- Understand the impact of GDPR and other regulatory frameworks on business as well as the pitfalls that companies should be award of that increase risk.
- 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.
- Examine and discuss the rigorous compliance environment in consideration of the blurred lines between care and research in medical device that present ethical and regulatory considerations.
- Determine ethical and regulatory consideration to ensure ethical decision making and compliance through case scenarios.
- Discuss the new FDA draft guidance to improve enrollment in underrepresented racial and ethnic populations.
- Understand techniques to increase female enrollment in clinical trials.
- Investigate improving the quality of outcomes and preventing mishaps by using prospective hindsight to spot potential blind spots in research.
- Comprehend the Notice of Proposed Rulemaking to harmonize FDA’s regulations on human subject research with those of the Common Rule
- Discuss recruitment and retention strategies.
- Identify the updates to the FDA compliance program manuals for Sponsors/CROs and Sites.
- Recognize CRA responsibilities from study start up to close out from the sponsor perspective and the helpful tools to assist process.
- Participate in speaker panel discussions held at the end of each day.