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Clinical Trial Events

SOCRA 18th Annual Device Research & Regulatory Conference

Apr 24–25

Apr 24–25, 2025 Ended

Hyatt Regency Newport Beach · Newport Beach, CA · In person

Join us for this annual event. hosted in Newport Beach, CA, as we gather device professionals for expert insights on medical device design, clinical trials, data analysis, quality, regulatory processes, and post-market management. This conference also offers attendees with a main program preceded by a half-day device basics preconference workshop. Don't miss this opportunity to explore the latest in device research!

Venue
Hyatt Regency Newport Beach
Program
1 track · 26 sessions
12 speakers

Agenda

Times in Newport Beach (PDT)
Wed, Apr 23 Thu, Apr 24 Fri, Apr 25

  1. 11:30 AM

    30 min

    Other · Preconference Workshop: Device Basics

    Preconference: Registration and Welcome

  2. 12:00 PM

    120 min

    Workshop · Preconference Workshop: Device Basics

    Preconference: Device Regulations & Classification

    Kathi Durdon, Upstate Medical University Angie Rock, BIOTRONIK, Inc.

  3. 2:00 PM

    20 min

    Break · Preconference Workshop: Device Basics

    Preconference: Break

  4. 2:20 PM

    60 min

    Workshop · Preconference Workshop: Device Basics

    Preconference: Roles and Responsibilities / Study Monitoring

    Angie Rock, BIOTRONIK, Inc.

  5. 3:20 PM

    60 min

    Workshop · Preconference Workshop: Device Basics

    Preconference: Overview of Premarket Submissions, Selecting, Preparing and Submitting the Application in the Correct Pathway

    Donna Headlee, Food and Drug Administration

  6. 4:20 PM

    40 min

    Other · Preconference Workshop: Device Basics

    Preconference: Q&A

  1. 8:00 AM

    30 min

    Other

    Registration and Continental Breakfast

  2. 8:30 AM

    10 min

    Other

    Program Welcome and Introduction

    Angie Rock, BIOTRONIK, Inc.

  3. 8:40 AM

    60 min

    Talk

    The ODD couple: Clinical Risk Management via ISO 14155 and ISO 14971

    Joy Frestedt, Frestedt Inc.

  4. 9:40 AM

    60 min

    Talk

    IDE’s Risk Determination

    Donna Headlee, Food and Drug Administration

  5. 10:40 AM

    20 min

    Break

    Break

  6. 11:00 AM

    60 min

    Talk

    Concept to Market for Medical Devices

    Kathi Durdon, Upstate Medical University

  7. 12:00 PM

    60 min

    Break

    Lunch

  8. 1:00 PM

    60 min

    Talk

    FDA Regulation of Digital Health Technologies, Artificial Intelligence and Machine Learning – An Evolving Regulatory Landscape

    Blake Wilson, Hogan Lovells

  9. 2:00 PM

    60 min

    Talk

    The Ethics and Regulation of Medical Device Innovation

    Quincy Byrdsong, Ballad Health

  10. 3:00 PM

    60 min

    Panel

    Day 1 Speakers Panel Discussion

    Joy Frestedt, Frestedt Inc. Donna Headlee, Food and Drug Administration Kathi Durdon, Upstate Medical University Blake Wilson, Hogan Lovells Quincy Byrdsong, Ballad Health

  1. 7:30 AM

    30 min

    Break

    Continental Breakfast

  2. 8:00 AM

    60 min

    Talk

    Regulatory and Compliance Considerations for Human Subjects Research: Recent Developments Affecting Informed Consent, Data Privacy, and Consumer Protection, including as Related to Digital Health Technologies Used in Research

    Leslie A. Thornton, Ropes & Gray LLP

  3. 9:00 AM

    60 min

    Talk

    Investigator-Initiated Device Studies – Key Concepts and Unique Challenges

    Andrea Volz, Dartmouth Health

  4. 10:00 AM

    20 min

    Break

    AM Break

  5. 10:20 AM

    60 min

    Talk

    Clinical Trial Budget Negotiation & Billing

    Sandra Sarafin, OhioHealth Research Institute

  6. 11:20 AM

    60 min

    Talk

    Statistics in Medical Device Research

    Austin Collins, Biomedical Statistical Consulting, LLC

  7. 12:20 PM

    50 min

    Break

    Lunch

  8. 1:10 PM

    60 min

    Talk

    Monitoring Collaboration for Effective Monitoring Visits

    Larissa Mitchell, Boston Scientific

  9. 2:10 PM

    60 min

    Talk

    Demystification of In Vitro Diagnostic Clinical Studies

    Narvelle Delabruere, Hologic, Inc.

  10. 3:10 PM

    50 min

    Panel

    Day 2 Speaker Panel Discussion

    Leslie A. Thornton, Ropes & Gray LLP Andrea Volz, Dartmouth Health Sandra Sarafin, OhioHealth Research Institute Austin Collins, Biomedical Statistical Consulting, LLC Larissa Mitchell, Boston Scientific Narvelle Delabruere, Hologic, Inc.

Speakers