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Susan Alpert, Ph.D., M.D.
Susan Alpert, Ph.D., M.D. Former Senior Vice President, Chief Regulatory Officer, Medtronic. Dr Susan Alpert was most recently the Senior Vice President and Chief Regulatory Office at Medtronic and was responsible for all Medtronic global regulatory efforts. Prior to joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. Dr. Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert serves on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products. Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University and holds a masters degree and Ph.D. in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Medical Center in Washington, DC.
Steve Binion, Ph.D., MBA
Steven B. Binion, Ph.D., MBA. Director, Corporate Regulatory/Women’s Health and Cancer, Becton Dickinson. Steve has spent over 25 years in industry, with 20+ years of increasing responsibility for pre- and post -market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory experience began in 1992, when he went to Allergan Pharmaceuticals as Director, Worldwide Regulatory, and Responsible Head for the company’s Botox biologic. In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs. For the next 10 years he led a global regulatory team with responsibility for the division’s 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical device products in the EU, including Class III devices incorporating medicinal products. In 2005 Steve joined Becton Dickinson and Company (BD) as Director of Regulatory Affairs in BD’s Corporate research center, BD Technologies, located in Research Triangle Park, NC. His responsibilities include providing support for early stage technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. He is active in a number of medical device and IVD policy issues on behalf of BD through his involvement in AdvaMed and several industry coalitions. Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, St. Paul, Minnesota.
Ann Marie Boullie
Ann Marie Boullie. Vice President, Emergo Group USA. Ann Marie Boullie is Vice President of Business Development for Emergo Group, an international regulatory and quality assurance consultancy focused on the medical device industry, and has worked with Emergo Group since 2006. Ann Marie helps North American based device companies navigate the regulatory process so they can start exporting to new markets throughout Latin America and has overseen the development and expansion of Emergo Group into the Latin American market. In this role, Ann Marie presents to and trains medical device manufacturers and industry groups on obtaining market access. Emergo Group has more than 2,500 medical device clients from 55 countries and was recently awarded a “Certificate of Appreciation for Achievement in Trade” by the US Commercial Service for their work in helping more than 1,000 medical device companies export their products in the last 5 years alone.
Gina Brackett. Compliance Officer. FDA Cincinnati District Office.(Confirmed)(conference co-chair)Gina has been with the Food and Drug Administration since 1990. Prior to taking the compliance officer position, she was the Medical Device Specialist in the Cincinnati District Office for 7 years. She is still a medical device performance auditor; and the majority of her case work involves medical device firms. She graduated from Thomas More College with a bachelor’s degree in Biology and an associate’s degree in Chemistry.
Paul Brooks. Vice President, Healthcare Solutions. BSI Product Services. Paul has worked with BSI since 1981, and is now responsible for leading BSI activities in the medical devices regulatory sector including EU Notified Body, EU/US Conformity Assessment Body, Health Canada / SCC CMDCAS accreditation and US FDA recognition. Paul was called upon to present and provide input on the FDA Modernization Act 1997, particularly regarding the use, role and acceptance of third party conformity assessment in regulatory requirements. Paul is a long standing member and Board Director of the Regulatory Affairs Professional Society (RAPS) and a member of American Society for Quality (ASQ) – Biomedical Division. He routinely presents and trains for RAPS, ASQ, AAMI, and AdvaMed. Paul was invited in Spring 2007 to join an International Accreditation Forum (IAF) Working Group to explore the wider acceptance of accredited ISO 13485 certification as a basis for helping to meet regulatory requirements for emerging regulations around the world.
Melissa Burns. Acting Associate Director for Guidance and Regulations, FDA. Melissa Burns currently serves as the Acting Associate Director for Regulations and Guidance in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE). In this role, she is responsible for review and development of guidance documents, regulations, and office policies and procedures related to premarket review. Prior to her Associate Director detail, Ms. Burns was a Regulatory Advisor for three years in ODE. Ms. Burns also spent four years as a Compliance Officer in the CDRH Office of Compliance (OC) and completed a detail as a Quality System Specialist in OC. Before starting her career at the FDA, Ms. Burns worked for several years in the private sector including positions with a medical device manufacturer, a large acute-care hospital, a healthcare architecture firm, and a consulting firm. Ms. Burns holds a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.
Jay Crowley. Senior Advisor for Patient Safety, Center for Devices and Radiological Health (CDRH), FDA (Confirmed). Jay Crowley is Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held variety of positions over his 20 years at FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.
Benjamin Dastoli. Investigator, Medical Device Specialist, FDA. (Confirmed) Ben has been with the FDA since 2000 conducting both domestic and foreign inspections of medical device manufacturers. Ben has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office and DOJ. Prior to joining FDA, he held positions of certified Senior Clinical Research Coordinator, CCRC, at Case Western Reserve University/ University Hospitals, Andrologist / Embryologist at Mt. Sinai Hospital and has conducted NIH sponsored research at the Cleveland Clinic Foundation. Ben is a graduate of Miami University, Oxford, OH.
Mark DuVal, President of DuVal & Associates. Mark DuVal, JD, is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical and nutritional supplement industries. His practice includes providing strategic regulatory advice, designing and implementing sophisticate marketing programs, counseling on reimbursement matters, developing compliance programs, conducting sales training and interfacing extensively on behalf of companies with the FDA. He works with FDA on behalf of companies on 510(k)s, de novos, combination products and PMAs, clinical trial IDE negotiations, inspections, warning letters, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems and several medical device divisions working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. in Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance providing FDA, Anti-kickback, False Claims Act, HIPAA, and other advice related to the FDA-regulated industry. Mark co-founded the Minnesota Medical Device Alliance (MMDA) and has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council (appointed by then Governor Pawlenty), and The Food and Drug Law Institute (FDLI) and was Chair of the Food, Drug and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs and Services program at St. Cloud State University.
Barbara Fant, Pharm.D. President and Principal Regulatory Consultant, Clinical Research Consultants, Inc. Barbara Fant, Pharm.D. is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC), and has 30 years of experience in pharmaceutical and medical device research and development. Prior to founding CRC, Dr. Fant spent several years directing and managing anti-infective clinical trials and pharmacokinetic studies with a major pharmaceutical company; established and directed a highly successful Phase I/Phase II academic-based clinical pharmacology research center at the University of Cincinnati; served as the Vice Chairperson and Associate Administrator for an independent institutional review board; and, was an Assistant Director for Clinical Research for a large contract research organization. Dr. Fant serves on the Board of Directors for Medennium, Inc. and directs the strategic planning for several start-up companies. She is the founder of the VEO Research Consortium and works closely with the European Vision Institute Clinical Trial Sites of Excellence consortium. Dr. Fant holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Christy Foreman,FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Device Evaluation. (Invited) Christy Foreman is currently the Director of the Office of Device Evaluation (ODE). Before being named to the Director position, she served as the Deputy Director for Science and Regulatory policy in ODE. She also worked in the Office of Compliance for 7 years as the Deputy Director for the Division of Enforcement B and the Branch Chief for the Orthopedic, Physical Medicine and Anesthesiology Devices Branch. Before joining OC, Ms. Foreman spent five years as a reviewer in the Anesthesiology and Defibrillator Devices Group in ODE. Before joining the FDA, Ms. Foreman spent seven years at the Naval Medical Research Institute in Bethesda, Maryland with specific research areas in environmental physiology and neuropharmacology. Ms. Foreman holds bachelors and masters degrees in biomedical engineering from The Catholic University of America. Additionally, she represents the FDA on standards organizations responsible for developing standards related to hyperbaric chambers and oxygen flammability and sensitivity of materials.
Laureen Genius. Investigator, Medical Device Specialist, FDA. (Confirmed) Laureen has been with the FDA since 1990. Laureen has extensive experience conducting medical device inspection for both domestic and international firms. Laureen is also a medical device performance auditor for FDA investigators, as well as assisting the accreditation of third party persons from Industry. Laureen has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office, CDC and DOJ. She is a graduate from Bowling Green State University.
Dennis Hahn, RAC
Dennis Hahn, RAC. Director, Regulatory Strategic Initiatives. Ethicon Endo-Surgery. Dennis is currently the Director of Regulatory Strategic Initiatives at Ethicon Endo-Surgery, a Johnson & Johnson Company. Mr. Hahn joined Ethicon Endo-Surgery in 1999. He has worked in the medical device industry for over 28 years, the past 18 in Regulatory Affairs. He has held positions of increasing responsibility in Research & Development, Engineering and Regulatory Affairs. Mr. Hahn has broad experience with in the registration of medical devices globally, with numerous 510(k) and PMA approvals to his credit, as well as significant approvals in Japan, Taiwan, China, Korea, Thailand, European Union and other markets. He has shaped medical technology policy while serving as a voting member on ANSI and ISO standards committees. He received his Bachelor of Engineering degree in chemical engineering from the Stevens Institute of Technology.
Suzanne Halliday. Team Leader, Orthopaedic & Dental Devices, BSI. Suzanne Halliday currently leads Training for BSI Healthcare. She has over nine years of experience as a Technical Specialist and Quality System Auditor for ISO 13485, CE Marking and certain aspects of compliance for Canada, USA, Japan, Taiwan and Australia. She has designed joint replacement implants, spinal and fracture fixation systems, and has conducted post market clinical investigations on orthopaedic implants. Suzanne holds a Bachelors and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).
Marian Lee. Partner, FDA & Life Science Practice Group, King & Spalding. In her role as partner in the FDA & Life Sciences Practice Group at King & Spalding, Ms. Lee advises medical device, pharmaceutical, and biotechnology companies on a broad range of FDA regulatory and compliance issues, including labeling and promotion, complaint handling and adverse event reporting, product recalls, product approvals, quality system regulation (QSR), device reclassifications, regulatory risk assessments, governmental investigations, and due diligence assessments of FDA-regulated entities. Ms. Lee has expertise in the FDA and FTC regulation of promotion and social media, and the regulation of mobile health (mHealth) technologies. She also previously served as an in-house regulatory counsel during a secondment to an international biopharmaceutical company. Law 360 named Ms. Lee a “Rising Star” in 2012, one of four attorneys nationwide in her field chosen for this recognition. She is a member of the Law 360 Life Sciences Editorial Advisory Board and Fellow to the Leadership Council on Legal Diversity, an organization of corporate chief legal officers and law firm managing partners committed to creating a diverse legal profession. At the firm, Ms. Lee serves as the Deputy Hiring Partner of the D.C. office. As pro bono counsel, she obtained withholding of removal on behalf of a Malian family seeking asylum from female mutilation practices. Ms. Lee graduated from Harvard Law School, where she was Articles Editor of the Harvard Journal of Law and Technology and Co-Chair of the Harvard Asian Pacific American Law Students Association. She graduated with a Bachelor of Arts, magna cum laude and Phi Beta Kappa, from Harvard College, where she received the Radcliffe College Presidential Award. Through a Fulbright grant, Ms. Lee previously served as a teacher in South Korea. She also conducted research on economic policy issues as an associate at Harvard Business School.
Tom Meyer. Senior Strategy Advisor, Xavier Health Initiatives. Tom Meyer leads the strategic planning process in Xavier University’s expanding Health Initiatives, and is Director of the joint FDA/Xavier MedCon and PharmaLink conferences. At Xavier, Meyer has been an Adjunct Instructor, Lecturer and Member of the Xavier Leadership Center. Meyer is a Senior Strategic Planning Consultant with the Cincinnati Consulting Consortium. Before embarking on a consulting career, Meyer had over 33 years of broad business experience with Procter & Gamble and Hewlett-Packard. Meyer’s expertise spans Strategic Planning, Organization Transformation, Brand Management, Quality Process Improvement (Six Sigma Master Black Belt), and Operations. Meyer holds a B.S. and M.S. in Mathematics from Xavier University.
David Miser. Director of Investigations Branch, FDA Cincinnati District Office. David has been with the Food and Drug Administration for 25 years. In his time with FDA he has worked as an Investigator in the Kansas City District Office, as the Senior Investigator in the Des Moines, IA Resident Post of the Kansas City District, a Supervisory Investigator in the Denver District Office and since September of 2012 as the Director of Investigations Branch in the Cincinnati District Office. He was a Level II Biologics Investigator and Auditor of both State Inspectors and FDA Investigators. He brings a strong background of regulatory compliance from multiple districts and positions to the Cincinnati District.
Thinh Nguyen. Director, Office of Combination Products. FDA. (Confirmed) Mr. Nguyen is the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ennsuring consistent and appropriate postmarket regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Mr. Nguyen spent 7 years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he had established significant policies and written numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Mr. Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, VA, from 1986 to 1993 where he was responsible for developing hardware/software for testing aircrafts and radar systems. Mr. Nguyen received a bachelor degree with honor in Electrical Engineering degree from North Carolina State in 1986.
Steven Niedelman. Lead Quality System & Compliance Consultant. King & Spalding. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.
James O’Reilly, J.D.
Prof. James O’Reilly, J.D. Professor. University of Cincinnati College of Law. Professor O’Reilly has been involved with FDA issues since 1974. He authored the standard reference encyclopedia on FDA for westgroup.com, which the U.S. Supreme Court quoted with the words, “The experts have written…”. He chairs the FDA committee of the American Bar Assn., is on the editorial board of the Food & Drug Law Journal, formerly chaired the programs committee of the Food & Drug Law Institute, and was keynote speaker at the FDA’s midwest celebration of its 100th anniversary in 2006. Before his academic career, he was principal FDA legal adviser for Procter & Gamble, and is the last active member of the team that negotiated the terms of the 1976 medical device amendments. He has published 45 texts and 180 articles since 1977.
Erik Paulsen. Congressman, U.S. House of Representatives. Congressman Erik Paulsen is a member of the U.S. House of Representatives Ways & Means Committee, which has jurisdiction over health care, economic and trade policy and is the chief tax writing committee in the House of Representatives. He supports pro-growth initiatives and believes that open markets are the key to a strong economy. He is also a member of the Free Trade Working Group and the Korea-U.S. Free Trade Working Group. The Free Trade Working Group was formed nearly 20 years ago to educate Members and promote policies that would open foreign markets to U.S. goods. Erik serves as co-chair of the House Medical Technology Caucus and is a leader in advocating for the medical technology industry, the life-saving technologies it provides to patients, and the hundreds of thousands of jobs it supports. Erik brings real-world experience to Capitol Hill with over 16 years of business experience, including working as a business analyst at Target Corporation. Before being elected to Congress in 2008, Paulsen represented Minnesotans for 13 years in the State Legislature where he served as House Majority Leader from 2003 to 2007. He received his B.A. in mathematics from St. Olaf College and resides in Eden Prairie with his wife and their four daughters.
Marla A. Phillips, Ph.D.
Marla A. Phillips, Ph.D. Director, Xavier Health Initiatives. Xavier University.(conference co-chair) Phillips joined Xavier University in 2008 as the Director of Health Initiatives, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries that bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries. Phillips aligns the mission of Xavier Health with the Strategic Priorities of the FDA. Phillips is the founder and co-chair of the FDA/Xavier University Medical Device Conference; founder and co-chair of the FDA/Xavier University PharmaLink Conference; founder and chair of the Integrity of Supply Initiative for the food, drug and device industries; and founder and chair of the Board of Directors for the QA/RA Institute of Xavier University. Additionally, Phillips serves as a consultant and expert witness to the pharmaceutical industry. Phillips started in the industry in 1996 when she was employed by Merck & Co., where she quickly took on positions of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility in 2000. Dr. Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.
Phil Phillips. President, Phillips Consulting Group, LLC. Phil Phillips has 30 years of experience in FDA regulation of medical devices, having focused on the development and implementation of numerous regulatory strategies regarding the design, manufacture and marketing of medical devices in the US. Mr. Phillips brings an in-depth knowledge of a wide range of regulatory matters, including FDA jurisdiction, device classification, clinical trials, and product labeling, including promotion and advertising. During his 24-year FDA tenure, Mr. Phillips streamlined the medical device review processes and launched numerous agency initiatives aimed at enhancing public health while lessening regulatory burden. In addition to serving as the Office of Device Evaluation’s Deputy Director for Science and Regulatory Policy for 12 years, he served as Director of Program Operations, Interim Director for the Division of General and Restorative Devices, Deputy Director for the Division of Ophthalmic Devices and the Chief of the Surgical and Diagnostics Devices Branch in DOD. Mr. Phillips holds a BS in Microbiology from the University of Maryland and a MBA from the George Washington University.
Phil Pontikos. National Device Expert. FDA. (Confirmed) Mr. Pontikos joined the FDA in 1994 as an Investigator in the Brunswick, Ohio Resident Post of Cincinnati District. In 2000, Mr. Pontikos moved to the Columbus, Ohio Resident Post where he currently resides. Mr. Pontikos was promoted to the Cincinnati District Medical Device Specialist position in October 2006. In January 2010, Mr. Pontikos became one of the National Experts in Medical Devices. Mr. Pontikos is a Level II Certified Medical Device Investigator and Performance Auditor performing inspections in program areas such as medical devices, pharmaceuticals, and bioresearch monitoring. He has participated as a course instructor for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, and the Industrial Sterilization course for Drugs/Devices. He has also served as a District Trainer for new hires and as a District Trainer for software applications such as OASIS and FACTS. Phil has a Bachelor’s degree in physics from Kent State University.
Susan Rolih. Senior Vice President, Regulatory Affairs and Quality Assurance. Meridian Bioscience, Inc. (conference co-chair) Susan has over 25 years of experience in the in vitro diagnostic device (IVDD) industry. Since joining Meridian Bioscience, she has been responsible for the quality oversight of Meridian’s diagnostic and Life Science affiliates in the US and Europe. She has extensive experience in due diligence assessments, design controls, quality auditing, process development, regulatory submissions and product training for both the IVDD and blood products industries. Susan earned her Bachelor of Science Degree from Arizona State University and her Master of Science Degree from the University of Cincinnati. She has authored numerous journal articles on blood group serology and has served as an editor for several reference books.
Heather Rosecrans. Senior Regulatory Advisor, Greenleaf Health LLC. Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health LLC. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
Dr. Jeffrey Shuren. FDA Director of the Center for Devices and Radiological Health (CDRH). (Confirmed)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. Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
Steve Silverman. FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Compliance.(Confirmed) Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 180 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations. Mr. Silverman also represents CDRH on agency-wide globalization initiatives and leads Center-wide compliance strategic planning efforts. He comes to this position from his role as Assistant Director of the Center for Drug Evaluation and Research’s Office of Compliance, where he helped lead a staff that applied federal laws and regulations governing the development, manufacture, labeling, and marketing of human drugs. Before joining the Center for Drugs, Mr. Silverman served as an Associate Chief Counsel in FDA’s Office of Chief Counsel. Mr. Silverman’s government service includes four-plus years as a trial attorney with the U.S. Department of Justice’s Tax Division, which he joined following his tenure with the Federal Trade Commission’s Financial Practices Division. He began his career in private practice. Mr. Silverman received his undergraduate degree cum laude from the University of Michigan. He attended the University of Pennsylvania law school, where he graduated cum laude and was an editor of the University of Pennsylvania Law Review.
Nancy Singer. Founder, Compliance Alliance. Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for those employed in the health care industry. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). While working on QSIT, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Nancy began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy received her B.S. from Cornell University , and J.D. and LL.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School, George Washington University Law School and compliance symposia at Harvard University. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve. Nancy’s email address is firstname.lastname@example.org.
Ginger Swassing. Director Regulatory Affairs, Abbott Vascular Division. Ginger joined Abbott in 1990. As director, regulatory affairs, Ginger leads the team that establishes and executes strategy for CE certification and maintenance of the CE Mark for Abbott Vascular’s medical devices. Prior to her current role at Abbott Vascular, Ginger was responsible for International Regulatory Affairs for Abbott’s Diagnostic Division. Ginger started her career in medical diagnostics at a subsidiary of Johnson & Johnson’s Ortho Diagnostics as a research scientist. In her 30 years of diagnostic and device related experience, Ginger has held leadership positions in Technical Product Development, Quality Systems, and Regulatory Affairs. Ginger earned a Bachelor of Science degree in Chemistry from the University of Denver and is RAC certified by RAPS in both US and EU regulations.
John Barlow Weiner. Associate Director for Policy, FDA, Office of Combination Products. John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.
Monica Wilkins. Divisional Vice President of Quality Assurance/Regulatory Affairs. Abbott. Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA). In her 12 years of FDA related experience, she held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Prior to FDA, her career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries holding the positions of Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant. Monica has a Bachelors degree in Microbiology from the University of Texas at Austin.
Winifred C. Wu, MBA, FRAPS
Winifred C. Wu. MBA, FRAPS, President, Strategic Regulatory Partners, LLC. Wini provides strategic regulatory advice to the medical device and pharmaceutical industries. Her expertise ranges from development and regulatory strategy for Class III devices, new drugs (NMEs), combination products, orphan drugs and humanitarian use devices, to ad-promo compliance. Wini “retired’ from Medtronic in July 2011 after 17 years, her last position as V.P. Regulatory and Medical Affairs of the Neuromodulation Sector. Wini’s 25+ years experience encompasses regulatory affairs, clinical research, quality/compliance, and program management. Her experience spans from global companies such as 3M and Medtronic to developmental phase biopharmaceutical companies. Wini is active in regulatory policies, having served in various working groups at AdvaMed. She is a regular speaker at conferences and is the lead instructor for the Ethics and Combination Products courses for theMasters in Regulatory Affairs program at St. Cloud State University. Wini holds a B.S. in Pharmacy from the University of Minnesota and a MBA from the University of St. Thomas. She is a Fellow of RAPS.