April 12, 2018 Session Speakers

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April 12, 2018 Session Speakers 7:30 8:30 Registration and Breakfast 8:30 8:45 Introduction to Conference George Flick 8:45 9:15 FDA s View of Compliance Captain Joseph Salyer (FDA) 9:15 10:00

1 April 12, 2018 Session Speakers 7:30 8:30 Registration and Breakfast 8:30 8:45 Introduction to Conference George Flick 8:45 9:15 FDA s View of Compliance Captain Joseph Salyer (FDA) 9:15 10:00 Non-Compliance An Industry Perspective Stan Mastrangelo 10:00 10:20 Break 10:20 11:00 Introduction to Products Liability How It Affects Medtech Companies and the Relationship between Products Liability and FDA Regulatory Compliance Sara Dyson, Courtney Young 11:15 11:45 Premarket FDA Regulatory Requirements Jeff Shapiro 11:45 12:30 Emerging Challenges for Medtech Companies Captain Joseph Salyer, Jeff Shapiro 12:30 1:15 Lunch - East/West Falls Church Room 1:15 2:00 Quality System Regulation (QSR) - Where Do Companies Go Wrong? Jeff Shapiro 2:00 2:45 Warnings, Labels, and IFUs and Products Liability Brian Donato 2:45 3:00 Break 3:00 3:45 FDA Regulatory Requirements for Clinical Studies Pitfalls to Watch Out For Jeff Shapiro April 13, :45 4:15 FDA Reporting & Products Liability Implications of Non-Compliance Kate Klaus 4:15 5:00 Most Effective Risk Management Practices for Life Sciences Companies Brian Donato, Courtney Young, Jeff Shapiro, 5:00 7:00 Reception - Falls Church Foyer 7:30 8:30 Breakfast 8:30 9:15 How Design Characteristics and Process Validation Affect Products Liability Alf Dolan 9:15 10:00 Regulatory Compliance & Products Liability from the In-House Counsel Perspective 10:00 10:45 The Failure-to-Warn Claim and How Your Sales Force, Advertising and Promotion Can Make It or Break It Roger Thies Sara Dyson 10:45 11:00 Break 11:00 11:30 Products Liability Managing Risk from Your Business Partners Courtney Young 11:30 12:15 Conclusions: Advice for Life Sciences Companies in Road Ahead Alf Dolan, Roger Thies, Sara Dyson 12:15 Adjourn

2 Speakers Alfred M Dolan has over forty-five years experience in the health care field across North America. Progressing from research in Thoracic and Cardiovascular field to Clinical Management and, finally to Health Care Program Management and Teaching. From it inception to 2016 Mr. Dolan has been the Convener of the Joint IEC/ISO Working Group on Application of Risk Management to Medical Devices which is the committee responsible for the Standard ISO 14971; Risk Management for Medical Devices, the world- wide standard in this area for all medical devices. He was also Chairman of the IECEE Task Force on implementation of risk management in the medical electrical equipment standard IEC for the world wide IECEE CB Scheme. Currently, he is President of Health Care Technology Consultants, the Samuel Lunenfeld Professor Emeritus in Clinical Engineering at the Institute of Biomedical Engineering, has served on the Board of Directors and on the Standards Policy Board of the Canadian Standards Association, and is a Past Chairman of the Board of Directors for the Association for Advancement of Medical Instrumentation. Brian J. Donato, Esq. is senior counsel at Hyman, Phelps & McNamara PC. Brian J. Donato began his career at Hyman, Phelps & McNamara, P.C. providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA's regulations and similar laws and regulations of the State of California. Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. From 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia in 1978 and He served as Lecturer at the University of Virginia School of Law from 1978 through Since 1982, he has been a faculty member at the University's Annual Trial Advocacy Institute. Sara E. Dyson, Esq. Sara Dyson is the Assistant Vice President of Risk Management for the Medmarc Insurance Group, which provides products liability insurance to the life sciences industry, primarily the manufacturers and distributors of medtech and pharmaceutical products. Ms. Dyson consults with life sciences companies to develop products liability risk management strategies and assist with related specialty areas, such as FDA compliance, post-market surveillance, product safety, and

3 recalls. She regularly performs evaluations of life sciences products and manufacturing operations to identify products liability risks and offer solutions to control potential losses and costs. Additionally, Ms. Dyson is the author of numerous articles on products liability risk management that have appeared in industry media outlets, such as Medical Device and Diagnostic Industry (MDDI) and Medtech Executive (MX) magazines. She also presents on the topic before industry groups and trade associations. In 2017, Ms. Dyson joined the Editorial Advisory Board of Medical Product Outsourcing (MPO) magazine. In 2012, Ms. Dyson was invited to join the Health Sciences Council for Underwriter s Laboratory (UL), a global independent safety organization that develops safety standards and certification programs for a variety of products. Ms. Dyson advises UL on safety trends for medical devices. Ms. Dyson received her law degree from the University of Wisconsin Law School and is a member of the Wisconsin and Virginia Bar Associations. She is also a graduate of the University of Michigan. George J. Flick, Jr. received his Bachelor, Master of Science and Doctoral degrees from Louisiana State University. He joined Virginia Tech after graduation and has been promoted to the rank of University Distinguished Professor. He has taught university credit and continuing education risk management courses for products regulated by the U. S. Food and Drug Administration. He has served as a Visiting Professor at the University of Tokyo and the National University of Mexico, Mexico City. His contributions to risk science have been recognized by the Vice President of the United States (Golden Hammer Award), U. S. Department of Agriculture, U. S. Department of the Army, Institute of Food Technologists, and American Association for the Advancement of Science. He has published five books, 51 book chapters and over 250 journal articles and manuals. Kathryn Tarallo Klaus, Esq., is a Risk Management Attorney with Medmarc Insurance Group. Her focus is on legal matters faced by participants in the life sciences industry, specifically FDA regulatory compliance. She began her career with FDA s Center for Biologics Evaluation and Research, where she worked on the Broad Spectrum Autism litigation under the National Childhood Vaccine Injury Act. After leaving FDA, she worked in private practice with two national law firms, counseling clients through all phases of the regulated product life cycle, including development and approval, manufacturing, labeling and advertising, and post-market concerns and enforcement. She has

4 advised clients regarding defense against regulatory enforcement actions, including FDA 483 Inspectional Observations, Warning Letters, U.S. Customs detentions, product recalls, and DHHS OIG exclusion proceedings. She has also counseled clients through all health law-related aspects of major transactions, from conducting facility and records compliance auditing during due diligence investigations, to federal and state licensure requirements, and the development and implementation of improved compliance programs post-closing. She now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing regulatory compliance strategies in an effort to mitigate products liability losses. Ms. Klaus is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross. Stan Mastrangelo retired from Abbott Laboratories after 24 years in Quality Assurance. He also worked in Medical Devices, Pharmaceuticals, and Food. He participated in the development of several International Standards related to Product Health and Safety Risk Management of Medical Devices and Pharmaceuticals. He was a member of the original committee that created ISO for Enterprise Risk Management. Stan has been teaching Risk Management university credit and continuing education courses since He has spoken in many different forums such as ASQ, AAMI, AdvaMed, Barnett, Virginia Tech, USC, Med Tech Intelligence, and others. Captain Joseph L. Salyer, RS, MPH is an Environmental Health Specialist in the U.S. Public Health Service. During his career he has served in many rolls including 21 years with the U.S. Food and Drug Administration. He is currently a regulatory operations officer in the Foreign Enforcement Branch, Division of International Compliance Operations, in the Center for Device and Radiological Health (CDRH). He also worked in the General Surgery Devices Branch and as a Field Investigator. While in the FDA, CAPT Salyer has worked with foods, drugs, devices, as well as imports. Captain Salyer completed a five year detail to the U.S. Coast Guard where he served as the Division Officer for Environmental Compliance. He was also assigned to the Indian Health Service where he worked on an Indian reservation. Captain Salyer served in the U.S. Army at the Medical Research Institute for Chemical Defense. He has provided risk management training for the

5 Department of Homeland Security, and conducted training and presentations throughout the United States, Canada, Puerto Rico, Egypt, Ireland, and China. Captain Salyer received his BS from Emory and Henry College, Emory, VA and his Masters of Public Health (MPH) from The Johns Hopkins University, Baltimore, MD. He currently resides in Leesburg, VA. Jeffrey K. Shapiro, Esq. is a director at Hyman, Phelps & McNamara PC. He specializes in medical device law, advising and representing companies before FDA for more than 20 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters. Mr. Shapiro also counsels clients on FDA requirements governing IVDs and HCT/Ps. Mr. Shapiro is an expert in FDA's regulation of combination products, including preparation of RFDs. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Mr. Shapiro recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies. Mr. Shapiro actively contributes to industry conversations on medical device regulations. He is a member of the Editorial Advisory Board for both MDDI and Update magazines, and co-editor of two textbooks, Promotion of Biomedical Products (Food and Drug Law Institute, 2006) and Combination Products, How to Develop the Optimal Strategic Path for Approval (FDA News 2005), and is a frequent speaker and contributor to the firm's FDA Law Blog, among other publications. Mr. Shapiro was a Lecturer and Fischell Literati teaching the University of Maryland's Regulatory Law: Medical Devices course. He currently serves on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute. Roger C. Thies, Esq. is senior counsel at Hyman, Phelps &McNamara PC. Prior to joining the firm in 1988, Mr. Thies was Vice President and General Counsel of G.D. Searle & Co. He joined Searle in 1970 as a staff attorney, counseling management on food, drug and device law issues. He also developed and managed the company's products liability defense efforts. Courtney Stevens Young, Esq. joined Medmarc in 2011 where she is now the Senior Attorney for Risk Management. Her primary responsibilities include the development of resources on products liability avoidance and regular correspondence with brokers, policyholders, and underwriters in efforts to evaluate and mitigate products liability risk. Ms. Young works with drug and device makers, component-part manufacturers, and raw-ingredient suppliers before and after products

6 liability claims to identify and assess their products liability exposures and mitigate future liability. She has also spent significant time in the analysis and development of the products/completed operations and errors and omissions insurance policies. Prior to joining Medmarc, she garnered both law-firm and government-agency experience in Washington, DC. Ms. Young is a frequently-published author on products liability risk management for industry organizations and publications. She also maintains a blog on products liability issues for the life sciences industry, on which she discusses recent products liability litigation, FDA regulatory activity, and industry news. Ms. Young received her law degree from the George Mason University School of Law, where she finished in the top quarter of her class, and is a member of the California and District of Columbia Bars. She is also a graduate of the University of California, Santa Barbara, where she received dual bachelor degrees in Business Economics and Political Science.

Jean W. Frydman Partner

Jean W. Frydman Partner Princeton, NJ Tel: 609.895.6630 Fax: 609.896.1469 jfrydman@foxrothschild.com A former general counsel for multinational pharmaceutical companies and a multinational retail dietary