Tuesday, December 6, 2022 (8:00 AM - 3:00 PM) (EST)
Join us for our Regulatory Roundup, designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry.
The agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. Again this year, we are thrilled to welcome Dr. Jeffrey Shuren MD, JD, Director - CDRH Offices: Office of the Center Director to provide us a briefing and participate in a moderated Q&A session.
A limited number of in-person tickets are available for $150, which includes meals, snacks and programming. A virtual-only ticket option is available for $100.
|8:00 - 8:05 am||Opening Remarks|
|8:05 - 8:50 am|
Trends in FDA Approvals
This session will inform you about what changes you can expect to encounter when seeking device approvals, including those in the digital health space.Presented by: RQM+
|8:50 - 9:35 am||The Current FDA Enforcement Landscape and Best Practices in Responding to 483 Observations||This presentation will provide an overview of medical device enforcement trends followed by a discussion of best practices and common pitfalls in responding to 483 Observations and Warning Letters.|
Presented by: Covington
|9:35 - 10:00 am||Networking Break|
|10:00 - 10:30 am||Interactions with the FDA: Q-Submissions, IDE and 510(k) ||The Q-Submission process, or Pre-Sub, is a regulatory pathway that allows you to request different types of medical device submission related communications with the FDA. In this tactical presentation, regulatory expert Eric Bannon, VP Regulatory and Clinical Affairs at AlvaMed, will provide an overview of the Q-Submission process, including how companies have used the process to receive FDA feedback on: regulatory pathway, test plans, review on clinical and non-clinical protocol outside of a 513(g) request. Insight will also be shared on how to advance to an IDE and 510(k) approval, including guidance on questions to expect and usual reasons for approval and disapproval.|
Presented by: Alvamed
|10:30 - 11:15 am||Navigating Complexities of Medical Software Regulation: SiMD, SaMD, and Mobile Apps|
Medical device software has evolved significantly since the original regulations and guidance documents of the 1990’s that primarily anticipated embedded software. The FDA has been hard at work identifying and classifying the expanding universe of device and digital health software that falls under their regulatory responsibility. An understanding of the new terminology (SiMD, SaMD, MDDS, etc.) used by the FDA will aid compliance with regulatory quality system and submission requirements. This talk helps you understand where your software fits in, what your regulatory responsibilities are for the software, and if they have changed.Presented by: Full Spectrum
|11:15 am - 12:00 pm|
When Innovation Outpaces Regulation: Updates on the latest FDA guidance on emerging technologies and its impact on products liability exposure
Colleen Hill and Sean Burke from Duane Morris will provide an update on the latest developments from the FDA as it relates to emerging technologies and innovation. As the FDA tries to keep up with fast paced innovation, suppliers, manufacturers and end users are left trying to employ best practices to comply with the newest guidance.Presented by: Duane Morris
|12:00 - 1:30 pm||Lunch & Networking|
|1:30 - 2:15 pm||CDRH Briefing & Moderated Q&A||This session will provide an overview of the latest updates from CDRH, followed by a moderated Q&A session led by Veeva MedTech where you will get the chance to ask your questions directly to Dr. Shuren!|
Presented by Veeva MedTech
|2:15 - 3:00 pm|
Commercialization of New Medical Devices
George Strom, Director of Intertek’s Connected World business, hosts a panel of medical and regulatory experts from Intertek to discuss the ever-changing requirements when launching new medical devices to market. These include topics such as safety, EMC, performance testing, cybersecurity and more covering both traditional med devices and new/emerging technologies.Presented by: Intertek
Jeffery E. Shuren, MD, JD
Director - CDRH Offices
Office of the Center Director
Food and Drug Administration
Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation. Read more.
Eric has led clinical trials on three continents and implemented successful regulatory strategies for multiple product areas, including Endoscopy, Orthopedics, Gastroenterology, and Metabolic Diseases. Eric’s regulatory successes include dozens of 510(k) submissions, CE mark approvals, Investigational Device Exemptions, De Novos and Pre-Submissions. He has built clinical operations teams to support the execution of large pre- and post-market clinical trials and has supervised complex trial record keeping and reporting for clients.
Bob is an experienced engineering leader and team builder with a focus on results. With technical strengths gained from more than 30 years in medical device systems engineering, systems and software validation, safety risk analysis, quality management and project management. Bob spent 15 years Baxter’s drug delivery division, where he led the systems engineering group. Bob has the role of player coach at Full Spectrum, leading the Systems Engineering Team, while providing his deep insights directly to our clients. Bob is a strong believer in cadence driven project management techniques. His ability to be hands-on or lead cross-functional teams accelerates our client’s medical development programs from concept to market release.
|Sean K. Burke|
Vice Chair, Products Liability and Toxic Torts Division
Trial Practice Group
Sean is a trial attorney representing and advising clients in the life sciences industry nationally in complex products liability matters. He regularly represents manufacturers of pharmaceuticals, biologics and medical devices in product liability cases, including in consolidated multi-plaintiff matters in both federal court (MDL) and state courts across the country. He also consults a diverse range of medtech and bio companies, including startups, on ways to mitigate the risks of products liability exposure, with a focus on emerging technologies such as 3d printing, artificial intelligence and robotics.
Matt is an innovative leader within the Life Sciences and Medical Device industry, joining Full Spectrum after leading Medical Device and Life Sciences in the Americas for Capgemini. A proven strategic thinker and leader with over 20 years in the healthcare industry, Matt has experience leading and growing businesses and divisions that maintain high and differentiated value in the market. An entrepreneur at heart, Matt understands the interplay and impact of technology, industry challenges/opportunities, and regulatory evolution and has worked throughout the industry forging the creative teaming relationships required to develop market changing products.
|Pamela F. Forrest|
Pamela Forrest has over 25 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.
Kevin Go, MBA, RAC, CQA
Attorney, Life Sciences and Medical Technology Industry Group
Colleen is a trial attorney representing clients in the life sciences industry in complex commercial disputes. She holds a leadership role in Duane Morris’ Life Sciences and Medical Technologies Industry Group. In addition, she helps pharmaceutical companies, biologics manufacturers, medical device manufacturers and pharmacies navigate the complex challenges faced by state and federal regulation for their industries.
Michael Owens has over 15 years of experience in medical device regulatory affairs. He started his career at FDA within CDRH’s Office of Device Evaluation (ODE) where he worked in the Division of Orthopedic Devices (recently rebranded to Office of Health Technologies Six or OHT6 within the Office of Product Evaluation and Quality (OPEQ)). He held positions as a Lead Reviewer, Team Leader, and Assistant Director within the Division of Joint Arthroplasty Devices. After over 14 years at the FDA, Michael took a position as a Senior Regulatory Affairs Manager at NuVasive where he now oversees a large portfolio of comprehensive spinal implants and instruments. He is responsible for developing and implementing regulatory strategies, overseeing all aspects of regulatory submission development, and interfacing with health authorities. Michael earned his bachelor’s degree from the University of Florida in Mechanical Engineering and his master’s degree in Biomedical Engineering from the University of Tennessee. He has also earned the Regulatory Affairs Certification (RAC (US)).
Senior Director, Regulatory Affairs and Quality Assurance
Business Development Director of IOT
George has worked with medical device manufacturers around the world to help them meet all of their assurance, testing, inspection, and certification needs. George’s 20+ years in the Quality Assurance & Safety arena bring insight into the unique challenges of launching a product in today’s Connected World. Prior to Intertek, George worked in Sales and Marketing within the Computer & Office Automation Industry. He is a proud alumnus of U-Mass Lowell and lives in the Greater Boston Area.
Senior Director, Government Strategy
As Senior Director of Government Affairs at Veeva MedTech, Amra is responsible for understanding the challenges and opportunities of medtech companies as well as representing the company in major industry associations to help foster industry progression. She has more than 23 years of experience in the Healthcare Industry, most of which were in large Medical Device companies in a variety of regulatory roles. Most recently, Amra led Regulatory Intelligence activities for Abbott’s Medical Device Division where her team was responsible for receiving, analyzing, and interpreting regulations that had the potential of impacting Abbott or wider industry. Prior to Abbott, Amra held leadership roles across regulatory, clinical, and quality at Bayer and Medtronic. She has also represented the medical device industry in various association working groups include Advamed, RAPS, WHO, IMDRF, and the FDA.
David Vogel was the founder and president of Intertech Engineering Associates, Inc. from 1982 to the 2020 merger with Full Spectrum. Intertech had served the medical device industry by providing medical device development and validation engineering services for a large variety of device manufacturers. During that tenure, he participated in hundreds of medical device projects for clients. David was also an active participant with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard. He worked with other joint AAMI/FDA workgroups to develop Technical Information Reports (TIR32:2004) for Medical Device Software Risk Management, and TIR36:2007 on the Validation of Software for Regulated Processes. As the author of Medical Device Software: Verification, Validation, and Compliance (2010, Artech Publishing), and as an AAMI instructor, Dave created and taught an AAMI workshop based on his textbook for nearly 10 years. David received a bachelor’s degree in electrical engineering and computer science from Massachusetts Institute of Technology, and from the University of Michigan he earned a master’s degree in bioengineering, a master’s degree in electrical and computer engineering, and a doctorate in bioengineering. Dave has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan, and was named as one of MD&DI Magazine’s “100 Notable People in the Medical Device Industry”.
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