From cybsecurity to remote inspections, recalls and quality management, medical technology regulations are rapidly expanding. This increase in global regulatory demands has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in device and software regulation, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.
Sessions are focused on informing and generating discussion among stakeholders, and include:
Preparing for Global Alignment in Quality Management System Regulation: An overview of FDA activities, projected timeline and insight into how you can begin to prepare for implementation of ISO 13485
Keisha Thomas is the Associate Director for Compliance & Quality, Office of Product Evaluation & Quality, Center for Devices & Radiological Health, FDA
The Case for Quality and Its Role in Premarket Approval
Bleta Vuniqi is the Lead CSO, Case for Quality Team, Center for Devices & Radiological Health, FDA. She has been with the FDA since 2010. Previously, Vuniqi was the Quality System Specialist within DMQ/OC, and Senior Program Expert in OPEQ/ORP/D1 focusing on PMA policy and process improvement. Before joining CDRH, she was an FDA investigator in ORA responsible for conducting medical device inspections and investigations.
Unique Device Identifiers: Meeting Regulatory Requirements Throughout the Product Lifecycle
Indira Konduri is the Deputy Director, Division of Surveillance Support (DSS), Office of Regulatory Programs (ORP), Office of Product Evaluation & Quality, CDRH, FDA
Regulatory Advocacy: Working with Industry Associations and Your Internal Team to Influence the Regulatory Environment
Lindsay Cobbs, U.S. Policy Head, BeiGene
Lindsay Cobbs, U.S. Policy Head at BeiGene, began his career as a staff pharmacist at The Johns Hopkins Hospital in Baltimore, before joining the FDA as special assistant and lead project manager in the Office of Compliance and later as associate director in the Office of Translational Research. Prior to joining BeiGene, he served as policy lead in the Global Regulatory and Policy Intelligence Division at Janssen Pharmaceuticals, a division of Johnson & Johnson and head of Americas, Global Regulatory Policy and Intelligence for UCB.
Recall Patterns: Enforcement Trends and What CDRH is Looking at Today
Paterson Shafer, Managing Director, FTI Consulting
Paterson Shafer has more than 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health authority interactions, submissions/approvals, labeling compliance, 483/Warning Letter/Consent Decree response and remediation program development and execution. Shafer is a strategic advisor to the FDA and has been co-leading collaboration efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality.
Are You Inspection Ready? How to Create an Inspection-Ready Team and Respond to Remote Assessment Requests
Steve Silverman, President, The Silverman Group
Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. His professional experience includes nearly two decades in federal service working at FDA, the U.S. Department of Justice, and the Federal Trade Commission. At the FDA CDRH Office of Compliance, Silverman led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization. He also served as Vice President, Technology and Regulatory Affairs at AdvaMed.
Securing Device Software: How To Meet Shifting Regulatory Guidances for Medical Device Software, Cyber Factors That Enable or Hinder Regulatory Success, and the Current Landscape of Postmarket Surveillance, Connectivity, And Encryption
Moderator: Shannon Lantzy, Ph.D., Vice President of Consulting, MedCrypt
Naomi Schwartz, Senior Director, Cybersecurity Quality & Safety, MedCrypt
Rina Bhagat, Senior Director of Quality & Regulatory, Synchron
Kyle Erickson, Senior Director Product Security, Medtronic
Learn more and register here.
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