May 2 and 3, 2024
Preconference - May 1, 2024
Angie Rock, MBA, CCRP, Director, Clinical Operations, Biotronik, Inc.
Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator
Donna Headlee, RN, BSN, CCRP, FDA, CDRH, OCE, DICE, PPB
11:30 – 12:00: Registration and Welcome
12:00 - 2:00: Device Regulations & Classification
Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator, and Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc.
2:00 - 2:20: Break
2:20 - 3:20: Roles and Responsibilities / Study Monitoring
Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK
3:20 - 4:20: Overview of Premarket Submissions, Selecting, Preparing and Submitting the Application in the Correct Pathway
Donna Headlee, RN, BSN, CCRP, FDA, CDRH, OCE, DICE, PPB
Several types of premarket submissions can be submitted to CDRH. In order to legally market a device in the US, the most common forms of premarket submissions to CDRH are the 510 (k) premarket notification submission, the PMA premarket approval and the De Novo Reclassification. This session will provide an overview of the various marketing pathways and discuss some best practices and strategies for submitting a premarket application.
4:20 - 5:00: Q&A
8:00 - 8:30: Registration and Continental Breakfast
8:30 - 8:40: Program Welcome and Introduction
Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc.
8:40 - 9:40: ISO 14155:2020 Overview and Comparison to FDA IDE Regulations
Joy Frestedt, PhD, RAC, CPI, FRAPS, FACRP, President and CEO, Frestedt Inc.
The FDA recognizes the ISO 14155:2020 international standard as a recognized consensus standard for good clinical practice (GCP) during medical device clinical trials. Investigational Device Exemptions allow an investigational device to cross state lines for use in clinical trials and the FDA regulations require these trials to follow GCP. This presentation will review the similarities and differences between the ISO 14155 international standard and the specific FDA IDE regulations in the US.
9:40 - 10:40: Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program
Gail Rodriguez, PhD, Senior Policy Advisor, CDRH, FDA
A reliance upon consensus standards reduces regulatory burden, streamlines conformity assessment, enhances device quality and promotes global harmonization. When manufacturers cite FDA recognized standards, uncertainty about conformity assessment documentation is reduced and less paperwork is required. This session introduces the audience to the practical aspects of citing standards in device submissions and offers tips on why and how to participate in the Accreditation Scheme for Conformity Assessment (ASCA), CDRH’s new initiative to streamline conformity assessment in device review.
10:40 - 11:00: Break
11:00 - 12:00: Lessons Learned: IDE Case Study
Donna Headlee, RN, BSN, CCRP, FDA, CDRH, OCE, DICE, PPB
This session will use a case study to discuss Investigational Device Exemption’s (IDE) regulatory framework including risk determination and navigating the IDE regulatory process.
12:00 - 1:00: Lunch (Provided)
1:00 - 2:00: Impact of the European Union General Data Protection Regulation and Other Privacy Laws on Clinical Research
David Peloquin, JD, Ropes & Gray LLP
In recent years, the European Union, as well as several other countries and U.S. states, have adopted stringent data privacy laws. These laws have had a profound effect on clinical research activities. This session will explore how the European Union’s General Data Protection Regulation (“GDPR”) applies to clinical research conducted in the European Economic Area. It will also explore the effects of emerging U.S. state privacy laws on clinical research.
2:00 - 3:00: The Ethics and Regulation of Medical Device Innovation
Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University
With the projected rapid growth in medical device development, oversight of medical device research becomes increasingly important. As a rigorous compliance environment will provide a key component of this oversight, the often blurred lines between care and research in medical device research present ethical challenges as well. This talk will look at case scenarios to determine the ethical and regulatory considerations of medical device research as well as strategies to ensure both ethical decision making and compliance are incorporated.
3:00 - 4:00: Day 1 Speakers Panel Discussion
Course Faculty
This panel discussion allows attendees an opportunity to query regulatory experts as an open interchange of hot topics, compelling questions, and day-to-day issues.
7:30 - 8:00: Continental Breakfast
8:00 - 9:00: Privacy & Confidentiality in the Age of Mobile Apps and Connected Devices
Robert Romanchuk, BSHS, CIP, Ethical Research Solutions, LLC
The widespread use of mobile apps and connected devices has become ubiquitous in clinical research, especially in the era of decentralized trials, further complicating the considerations of privacy and confidentiality in the protections of research subjects. This session will describe the scope and reach of digital devices and apps, their regulatory status and oversight, and zero in on how their use impacts subject privacy and confidentiality.
9:00 - 10:00: Investigator-Initiated Device Studies – Key Concepts and Unique Challenges
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
This presentation will focus on device studies that are sponsored by a single investigator. Navigating the regulatory landscape, from both the sponsor and investigator role, requires a specific level of expertise. Appreciating the operational fundamentals while anticipating potential barriers are essential to finding success in this area. This presentation will focus on these areas, providing educational content that aims to enhance the audience’s device skillset within the context of investigator-initiated trials.
10:00 - 10:20: AM Break
10:20 - 11:20: Effective Management of Clinical Trial Financials
Sandra Sarafin, BA, CCRP, Director of Research Business Services, OhioHealth Research Institute
Ms. Sarafin will discuss how to create comprehensive internal budgets to ensure costs for trials are covered, share sponsor negotiation strategies, and discuss how to manage finances post award. This session will also cover medical device implications in budgeting and contracting.
11:30 - 12:20: Collaboration for Effective Monitoring Visits
Larissa Mitchell, CCRP, Senior Clinical Research Associate, ICON
This talk will discuss ways for effective and increased collaboration between site staff and monitors for both onsite and remote monitoring visits.
12:20 - 1:10: Lunch (Provided)
1:10 - 2:10: Use of Clinical Adjudication for Determination of the True Infection Status in the Absence of Reference Standard
Shailee Rasania, MPh, MBA, M.S, CCRP, Clinical Operations Manager, Inflammatix, Inc.
Use of clinical adjudication in clinical trial design is increasing since past decade. One of the biggest challenges we face in conduct of clinical trials in infectious disease domain is the absence of true gold standard/ reference standard to determine the true infection status. Using clinical adjudicators is becoming a popular solution to this problem. Many companies have successfully used clinical adjudication as reference standard for their FDA submission and has led path for this method to become widely accepted in clinical trials.
2:10 - 3:10: Introduction to Statistics in Medical Device Research
Austin Collins, MS, Senior SAS Programmer, Biomedical Statistical Consulting
This presentation will provide an introduction and overview of clinical trial statistics. Descriptive statistics, multiple types of statistical testing, power calculations, and survival analysis will all be covered. The end of the presentation will explore a few example journal articles
3:10 - 4:00: Day 2 Speaker Panel Discussion
Course Faculty
This interactive session allows the participants to discuss issues related to medical device investigational studies.