Main Program: April 27 and 28, 2023
Special Half-day Preconference Workshop: April 26, 2023*
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
Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc., and Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator
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 - 4:50: Q&A
8:00 - 8:30: Registration and Continental Breakfast
8:30 - 8:40: Program Welcome and Introduction
Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator, Upstate Medical University, Syracuse, NY
8:40 - 9:40: Devices, Detection, and Quality by Design (QbD) - 3D Success
Mary Sophy Yohannan, MBBS, Med. Device Clinical Scientist – Galvanize Therapeutics, Inc.
This talk will focus on how applying quality by design principles within the medical devices space increases participant safety and data quality while supporting trial efficiency.
9:40 - 10:40: FDA’s Digital Health Centers of Excellence Program (DHCoE) Overview of Resources
Glenda Guest, CCRA, RQAP-GCP, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training
The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. A positive outcome of the COVID pandemic is the more rapid evolution and adoption of these technologies. Learn about the evolution of FDA DHCoE and plans for such things as Artificial Intelligence(AI), Machine Learning (ML), Cybersecurity and more.
10:40 - 11:00: Break
11:00 - 12:00: Career Planning: Acquiring Competencies & Champions
Erika Stevens, MA, FACRP, Principal Consultant/Faculty Lecturer, RTR/Rutgers
Career pathways in the clinical research device industry require diverse skills and capabilities. This session describes resources for professional development and provides insights for leveraging support in career growth.
12:00 - 1:00: Lunch (Provided)
1:00 - 2:00: GDPR and Other Regulatory Frameworks
Carl Carpenter, CEO, Arrakis Consulting, San Tan Valley, AZ
The impact of GDPR and other regulatory frameworks that can have an effect on your business. Potential pitfalls that companies should be aware of that can increase risk. Potential loopholes that can reduce risk.
2:00 - 3:00: Breakthrough Devices Program and Safer Technologies Program (STEP)
Donna Headlee, RN, BSN, CCRP
This presentation will provide an introduction to the Breakthrough Devices Program and Safer Technologies Program. The goal of both programs is to provide patients and health care providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote the public health. This presentation will include an explanation of the principles and benefits of each program, eligibility considerations, and program features available to Breakthrough and STeP
3:00 - 4:00: Day 1 Speakers Panel Discussion
This panel discussion will allow 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: 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.
9:00 - 10:00: Increasing Female Enrollment in Clinical Studies
Karlene Cox, BS, CCRP, CRA Manager, BIOTRONIK
With the recent April 2022 FDA draft guidance to improve enrollment in underrepresented racial and ethnic populations in clinical trials, Diversity, Equity and Inclusion (DEI) is more prevalent than ever in clinical trials. This talk will include high level review of the recent FDA DEI related guidance, with an emphasis on how to successfully increase female enrollment in clinical trials. Specific techniques and guidance regarding increasing female enrollment will be included based upon a recent clinical trial which successfully increased female enrollment as part of a protocol defined enrollment expectation. The need to focus upon changes in enrollment techniques to increase diversity in clinical trials is essential and will impact all future clinical trials.
10:00 - 10:20: AM Break
10:20 – 11:20: Imagining Failures to Identify Blind Spots in Device Research
David Staley, MA, Director of Clinical Research Quality Assurance and Regulatory Support, Seattle Children's Hospital Research Institute
Risk analysis can be useful in identifying problems. Research also supports another approach.
Prospective hindsight, imagining failures beforehand, offers advantages in improving the quality of
outcomes and preventing mishaps. Participants in this session will examine the strategy of using
prospective hindsight to spot potential blind spots in research. Using prospective hindsight,
participants will assess a research study involving a device to identify potential blind spots that could
negatively affect the quality of the study’s outcomes. Then, participants will suggest changes to the
study’s operations to improve the outcomes.
11:20 - 12:20: What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule
David Peloquin, JD, Partner, Ropes & Gray, LLP
In September 2022 the FDA released a long-awaited Notice of Proposed Rulemaking to harmonize the FDA’s regulations on human subject research with those of the Common Rule. This presentation will provide an overview of the proposed rule, key items not addressed in the proposed rule, and practical implications for those conducting medical device research.
12:20 - 1:10: Lunch (Provided)
1:10 - 2:10: Updates to the FDA Inspectional Guidances
Brandy Chittester, MS, Executive Vice President and Chief Strategy Officer, M&B Sciences,Inc.
In the past two years, both of the compliance program manuals for Sponsors/CROs and Sites have been updated. These manuals guide FDA inspections. This talk will discuss the changes to the inspectional instructions and what sites, sponsors and CROs can do to prepare for the updates.
2:10 - 3:10: The Challenges of Subject Enrollment and Retention in a Longitudinal Study
Scott L. Wehage, MS, CCRP, Director, Clinical and Rural Health, St. Lawrence Health
The talk will review enrollment and retention practices, pitfalls and mitigations for large, multi-center, longitudinal studies. We will review some real life mitigation strategies that work!
3:10 - 4:10: Question & Answer Session and Discussion
This interactive session will allow the participants to discuss issues related to medical device investigational studies.