{"id":743,"date":"2023-03-10T07:04:00","date_gmt":"2023-03-10T07:04:00","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=743"},"modified":"2023-07-10T00:18:37","modified_gmt":"2023-07-10T00:18:37","slug":"10-reasons-to-attend-the-16th-annual-device-research-regulatory-conference","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/10-reasons-to-attend-the-16th-annual-device-research-regulatory-conference\/","title":{"rendered":"10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference"},"content":{"rendered":"\n
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Angie Rock<\/p>\n\n\n\n

MBA, CCRP<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n

\n
\"\"<\/figure>
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Kathi Durdon<\/p>\n\n\n\n

MA, CCRP<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n

Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices \u2013 so she created one.<\/p>\n\n\n\n

\u201cMy initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,\u201d said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi\u2019s vision, and the Annual Device Research & Regulatory Conference was born.<\/p>\n\n\n\n

\u201cThanks to SOCRA\u2019s support, I could create a different kind of conference \u2013 one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas \u2013 not just one or two areas,\u201d Kathi recalled.<\/p>\n\n\n\n

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it\u2019s still the medical device research \u201cgo to\u201d conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.<\/p>\n\n\n\n

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi\u2019s tenure, to discuss the importance of the program, and to discuss future plans for the conference.<\/p>\n\n\n\n

\u201cThis conference is Kathi\u2019s brainchild. I\u2019m honored to be a part of this phenomenal program \u2013 it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,\u201d said Angie.<\/p>\n\n\n\n

In this post, we\u2019ll outline Kathi and Angie\u2019s top ten reasons to attend this annual conference and why it\u2019s important for device newbies and experts alike.<\/p>\n\n\n\n\n\n\n\n

Top 10 Reasons to attend the annual Device Research & Regulatory Conference in 2023<\/h2>\n\n\n\n

1. It was created by device professionals for device professionals<\/h3>\n\n\n\n

As a device professional, Kathi designed the Device Research & Regulatory Conference to provide industry professionals with the tools, knowledge, information, and connections to succeed in their careers. Attendees should expect content and discussions that are offered on a range of relevant topics, including regulatory compliance, innovation and device development, and requirements for clinical investigations.<\/p>\n\n\n\n

2. You will learn how to navigate the regulatory landscape<\/h3>\n\n\n\n

Angie pointed out that medical device research is drastically different from pharmaceutical research, in part, due to the complexity of regulatory pathways in bringing devices to market in the U.S. With so many intricacies and gray areas in the regulatory landscape, Angie believes that it\u2019s critical to learn how to navigate the varying pathways. \u201cI know that when I started, I had very little knowledge regarding the regulatory issues and opportunities, and this conference helped to provide a framework for navigating them,\u201d said Angie.<\/p>\n\n\n\n

3. Fantastic keynote speakers on hot topics<\/h3>\n\n\n\n

In keeping with Kathi\u2019s vision for dynamic keynote and conference speakers discussing hot topics, this year\u2019s speaker schedule is brimming with notable industry leaders and must-see presentations, including:<\/p>\n\n\n\n

\u00b7 Device Regulations & Classifications \u2013 <\/strong><\/p>\n\n\n\n

Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc., and Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator<\/em><\/p>\n\n\n\n

\u00b7 Overview of Premarket Submissions <\/strong><\/p>\n\n\n\n

Donna Headlee, RN, BSN, CCRP<\/em><\/p>\n\n\n\n

\u00b7 Devices, Decentralized Research, and Quality by Design \u2013 3 Pillars to Success <\/strong><\/p>\n\n\n\n

Brian Barnes, MA, Senior Director, Product Development, Medidata Solutions<\/em><\/p>\n\n\n\n

\u00b7 FDA\u2019s Digital Health Centers of Excellence Program (DHCoE) Overview of Resources <\/strong><\/p>\n\n\n\n

Glenda Guest, CCRA, RQAP-GCP, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training<\/em><\/p>\n\n\n\n

\u00b7 Career Planning: Acquiring Competencies & Champions <\/strong><\/p>\n\n\n\n

Erika Stevens, MA, FACRP, Principal Consultant, Recherche Transformation Rapide, Faculty Lecturer, Rutgers University<\/em><\/p>\n\n\n\n

\u00b7 GDPR and Other Regulatory Frameworks <\/strong><\/p>\n\n\n\n

Carl Carpenter, CEO, Arrakis Consulting<\/em><\/p>\n\n\n\n

\u00b7 Breakthrough Devices Program and Safer Technologies Program (STEP) <\/strong><\/p>\n\n\n\n

Donna Headlee, RN, BSN, CCRP<\/em><\/p>\n\n\n\n

\u00b7 The Ethics and Regulation of Medical Device Innovation <\/strong><\/p>\n\n\n\n

Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University<\/em><\/p>\n\n\n\n

\u00b7 Increasing Female and Minority Enrollment in Clinical Studies <\/strong><\/p>\n\n\n\n

Karlene Cox, BS, CCRP, CRA Manager, BIOTRONIK<\/em><\/p>\n\n\n\n

\u00b7 Imagining Failures to Identify Blind Spots in Device Research <\/strong><\/p>\n\n\n\n

David Staley, MA, Associate Director, Advarra\u2019s Institutional Research Center of Excellence<\/em><\/p>\n\n\n\n

\u00b7 What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule <\/strong><\/p>\n\n\n\n

David Peloquin, JD, Partner, Ropes & Gray, LLP<\/em><\/p>\n\n\n\n

\u00b7 Updates to the FDA Inspectional Guidance Documents <\/strong><\/p>\n\n\n\n

Brandy Chittester, MS, Executive Vice President and Chief Strategy Officer, M&B Sciences, Inc.<\/em><\/p>\n\n\n\n

\u00b7 The Challenges of Subject Enrollment and Retention in a Longitudinal Study <\/strong><\/p>\n\n\n\n

Scott L. Wehage, MS, CCRP, Director, Clinical and Rural Health, St. Lawrence Health<\/em><\/p>\n\n\n\n

4. Discover industry trends and how to put them into practice<\/h3>\n\n\n\n

This conference provides a unique opportunity to discover the latest medical device research trends and offers expert predictions for the industry\u2019s future. Kathi and Angie hope that attendees will walk away with a greater understanding of industry trends and practical ways to incorporate them into their daily practice.<\/p>\n\n\n\n

5. Connect and network with other device professionals<\/h3>\n\n\n\n

One of Kathi\u2019s primary goals when creating this program was to offer an opportunity to connect and collaborate. So, expect plenty of opportunities to network with fellow medical device professionals at this 2-1\/2 day conference. If you want to make the most of your experience, check out these helpful tips for networking at scientific conferences.<\/p>\n\n\n\n

6. Share your knowledge and get advice<\/h3>\n\n\n\n

The Device Research & Regulatory Conference allows ample opportunity to share knowledge through interactive presentations and Q&A sessions. \u201cIf we didn\u2019t hit on a topic an attendee is interested in, we invite them to share that topic with the group so that we can work together to solve a problem, find resources, or offer suggestions,\u201d said Kathi. Angie added, \u201cI love working with teams and mentoring individuals, and the device conference is a great platform for sharing education and experience with people seeking advice.\u201d<\/p>\n\n\n\n

7. Discover career development opportunities<\/h3>\n\n\n\n

This conference offers plenty of educational sessions and opportunities to connect and network with \u201cmovers and shakers\u201d in the medical device industry, making it an excellent forum to also explore career development opportunities. Whether you\u2019re looking to upskill, discover new opportunities, or find a mentor, the Device Research & Regulatory Conference has it all. You will also earn CME, CNE and SOCRA continuing education credit hours by attending the conference and the optional Device Basics preconference workshop.<\/p>\n\n\n\n

8. It\u2019s a valuable resource for startups and for those new to device research<\/h3>\n\n\n\n

With Kathi\u2019s background and experience in helping medical device startups navigate the process of bringing safe and effective devices to market, she passionately encourages device innovators to attend this conference. \u201cI love my job because I get to work with students, faculty members, and small company representatives with ideas for new devices in responses to unmet needs,\u201d she said. \u201cSome of the proposed technologies blow my mind! However, it can be a daunting task when you\u2019re unsure which development path is potentially the most effective, especially on a limited budget. That\u2019s where I and the incredible resources at this conference come in. We\u2019re here to help big ideas succeed because innovation is essential for economic development.\u201d<\/p>\n\n\n\n

9. There will be something for everyone<\/h3>\n\n\n\n

The Device Research & Regulatory Conference is geared for attendees with a range of roles and responsibilities, including:<\/p>\n\n\n\n

\u00b7 Clinical Research Professionals (e.g., Clinical Investigators, Clinical Research Associates, Clinical Research Coordinators, Program Managers, etc.)<\/p>\n\n\n\n

\u00b7 Government, University\/Academic, Industry, and Support Organization Representatives<\/p>\n\n\n\n

\u00b7 Quality, Regulatory, Research and Development, Engineering, and Human Factors professionals<\/p>\n\n\n\n

\u00b7 Medical Device Designers\/Developers<\/p>\n\n\n\n

\u00b7 Medical Device Startup Companies<\/p>\n\n\n\n

\u00b7 Medical Device Vendors and Service Providers<\/p>\n\n\n\n

\u00b7 Contract Research Organization (CRO) specialists<\/p>\n\n\n\n

\u00b7 All others interested in learning more about medical device research and the medical device development regulatory process<\/p>\n\n\n\n

Angie Rock noted that the conference is great for new and experienced research professionals alike, \u201cEveryone will leave the conference with new information and additions to their professional network.\u201d and \u201cOur audience\u2019s backgrounds are an even mix of site-oriented and sponsor-related professionals, giving attendees many opportunities to talk to other researchers about their \u201cpain points,\u201d and how they can work together for a better outcome.<\/p>\n\n\n\n

10. Help advance the release of new device technologies<\/h3>\n\n\n\n

Finally, the Device Research & Regulatory Conference offers a place to learn and connect as we work toward a universal goal: to release safe and effective medical technologies to the market. \u201cWhat motivates me every day is to help drive development so that clinicians are more efficient in their diagnoses and treatments and patients can experience improved outcomes,\u201d said Angie. \u201cThis conference allows you to connect with a diverse group of people to help you to address and satisfy the high level of compliance requirements and scientific rigor that will ensure the safety of all research participants, as we work toward releasing safe and effective devices.<\/p>\n\n\n\n

To learn more about the 16th Annual Device Research & Regulatory Conference or register for this premier conference for medical device professionals visit the links above or email us at office@socra.org.<\/p>\n","protected":false},"excerpt":{"rendered":"

Angie Rock MBA, CCRP Kathi Durdon MA, CCRP Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices \u2013 so she created one. \u201cMy initial incentive for starting an annual device conference was because I needed help. I … <\/p>\n

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