Training Program Title
Device Research & Regulatory Conference: The Premier Conference for Device Professionals
CTSA Hub Administered
Contact us by email at firstname.lastname@example.org or call us at 215-822-8644.
Training Program Description
Goal: This annual medical device conference, now in its 13th year, provides attendees with 2 days of speakers from FDA, site, industry and clinical research/regulatory support organizations. We also host a Pre-Conference Half-Day Workshop as an add-on to the Main Program.
Attendees Include the Following Roles and Responsibilities:
- Quality, Research and Development, Regulatory
- Clinical Research Associates, Clinical Research Coordinators
- Government, University, Industry Representatives
- Engineering, Human Factors
- Medical Device Designers/Developers
- Medical Device Startups
- Medical Device Vendors, Service Providers
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 and includes:
- Demystifying Medical Devices
- How Can Knowledge of Good Laboratory Practice (GLP) Regulations Make Your IRB Minimize Patient Risks?
- What is Q-sub and the FDA’s Pre-Submission Program
Main Program – Day 1 Presentations Include:
- Introduction to the 510(k) Program and Case Study
- Introduction to the PMA Program
- A Key Resource for Industry – Working with the CDRH Office of the Ombudsman
- Navigating the FDA/CDRH Website
- US Clinical Trial Reimbursement
- Balancing the Clinical Trial Budget
- Panel Discussion
Main Program - Day 2 Presentations Include:
- The Ten Best Innovation Practices Among Healthcare Innovation Centers
- Risk Management in Medical Device
- European Union Changes in Medical Device Regulations
- Medical Post Market Clinical Follow-up (PMCF): Adjusting to the “new normal” in the MDR Era
- Managing Medical Device Product and Project Lifecycles in an Evolving Regulatory Landscape
- Medical Device Jeopardy
Device, Product development, Research study management, Regulation, Best practice
Digital Commons Disciplines
Cost to Access
Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
- Discuss FDA regulations including risk categorization and device classifications.
- Describe Good Laboratory Practice and how it can be used to assist IRB review.
- Discuss FDA CDRH Pre-Submission process.
- Discuss during Question & Answer with speakers to gain additional understanding of the FDA Regulatory Process and particular experiences.
Learning Objectives: Conference
The participant will be able to:
- Discuss 510(k) process relative to submission requirements.
- Describe the Premarket Approval Program assessing safety and effectiveness of Class III devices.
- Discuss value and process to utilize Ombudsman resources, particularly for dispute resolution.
- Describe resources available through the FDA CDRH website.
- Discuss US clinical trial reimbursement.
- Apply budget approaches to maximize reimbursement and expectations.
- Discuss a DUKE-led study regarding how healthcare innovation centers launched initiatives and how they compare to industry.
- Discuss risk management and the total product life cycle and human factors related process.
- Explain European Union Changes in Medical Device Regulations that will impact compliance.
- Comprehend Post Market Clinical Follow-Up
- Discuss tools and process to promote a partnered approach to protocol development.
- Actively discuss issues and topics germane to attendee roles and responsibilities
Clinical Research Professionals (other than PI)
2 Day Conference (17.75 hours of CE credit available)