Training Program Title

Device Research & Regulatory Conference: The Premier Conference for Device Professionals

CTSA Hub Administered

no

Contact Information

Contact us by email at office@socra.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

Competency Keywords

Device, Product development, Research study management, Regulation, Best practice

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

yes

Competency Domains

Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management

Learning Objectives

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

Delivery Method

In-person

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

Annually

Time Needed

2 Day Conference (17.75 hours of CE credit available)

Associated Assessment

yes

Assessment Methods

Overall satisfaction

Share

COinS