In an increasingly digital world, medical device regulators and regulatory professionals have more information than ever to help them identify adverse events and new indications. Combined with shifting U.S. and global regulatory requirements, the task of staying abreast of new requirements and data sources is becoming a Herculean task.
On May 16-17, device developers, regulators, and regulatory affairs and intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
The MedTech Regulatory Intelligence Summit offers sessions covering current and emerging FDA CDRH areas of focus as well as international medical device regulations and best practices in streamlining your pre-market and post-market surveillance processes. Speakers include:
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.
Reaching the Asian Market: Certification Challenges and Considerations for China and Japan
Ames Gross, President, Pacific Bridge Medical
Ames Gross has helped hundreds of medical companies with business development and regulatory issues in Asia. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences.
Preparing for Global Alignment in Quality Management System Regulation: ISO:13485
Keisha Thomas, Associate Director for Compliance & Quality, Office of Product Evaluation & Quality, Center for Devices & Radiological Health, FDA
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.
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, safety and surveillance, and commercial compliance. 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.