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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.


Winifred  Wu, MBA

Winifred Wu, MBA

President and Principal Advisor, Strategic Regulatory Partners, LLC, United States

Elizabeth  Baker

Elizabeth Baker

Group Manager Licensing Division, Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom

A pharmacist with a Masters in Biopharmacy Liz began her career in pharmaceutical R&D. She has over 20 years’ experience in regulation. She is now a Group Manager in the medicines Licensing Division of MHRA responsible for multidisciplinary teams of assessors. In addition to wide-ranging activities in medicines licensing Liz is involved in handling medicine-device combination products, oversight of Notified Body consultations on ancillary medicinal products and in the policy and practice on the medicines-device borderline at national and European level. Liz also participates in the EMA’s Innovation Task Force, Innovation Network and sits on the British Pharmacopoeia Pharmacy Expert Group.

Jill  Hartzler Warner

Jill Hartzler Warner

Associate Commissioner for Special Medical Programs, OC, FDA, United States

Jill is Associate Commissioner for Special Medical Programs at FDA. She oversees FDA’s Office of Pediatric Therapeutics, Office of Orphan Products Development, Office of Good Clinical Practice, Office of Combination Products, and the Advisory Committee Oversight and Management Staff.

Steven  Hertz, MBA, MS

Steven Hertz, MBA, MS

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER , FDA, United States

Mr. Hertz is an officer in FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality. He has been with FDA since 2008 and his work is focused on pre-approval process and facility assessment. He is an office subject matter contact for issues regarding computer validation, combination products, control systems, electronic records, bio-pharmaceutical engineering, QbD, PAT, and process validation. He earned his B.S. in chemical engineering from the University of Virginia, his M.S. in biotechnology and his M.B.A. from Johns Hopkins University, and is a licensed Professional Engineer in the state of Maryland.

Patricia  Love, MD, MBA

Patricia Love, MD, MBA

Deputy Director, Office of Combination Products, OCPP, OC, FDA, United States

As Deputy Director of the Office of Combination Products since 2003 Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from 1993-2003, Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products. She joined FDA in 1988 and has a range of FDA review and leadership experience in therapeutic, diagnostic, and combination product areas. Dr. Love is an internist with rheumatology, and allergy-immunology academic and clinical practice experience.

Thinh X. Nguyen

Thinh X. Nguyen

Director, Office of Combination Products, OCPP, FDA, United States

Mr. Nguyen is the Director of the Office of Combination Products (OCP) since January 2008. OCP is primarily responsible for making jurisdictional determinations, ensuring timely premarket reviews, ensuring consistent and appropriate post-market regulations, and developing policy, guidance documents, and regulations. Mr. Nguyen joined the agency in 1993 as a scientific reviewer in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). From 2000 - 2007, Mr. Nguyen was the Chief of the Pre-Market Approval Program in CDRH where he was primarily responsible for ensuring the uniform and consistent application of the PMA regulations and policies across CDRH and CBER.

Kirsten H. Paulson, MS, RAC

Kirsten H. Paulson, MS, RAC

, Pfizer, Inc., United States

Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.

John  Weiner, JD

John Weiner, JD

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).

Irene Z. Chan, PharmD

Irene Z. Chan, PharmD

Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE, , FDA, United States

CAPT Irene Z. Chan received a B.S. in Pharmacy and Doctor of Pharmacy degree from Rutgers University. CAPT Chan currently works at the Food and Drug Administration where she serves as Deputy Director in the Division of Medication Error Prevention and Analysis, responsible for leveraging her knowledge of regulations, human factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design.

Aaron  Kemp

Aaron Kemp

Senior R&D Manager, BD Medical, Pharmaceutical Systems, United States

William  H.  Maisel, MD, MPH

William H. Maisel, MD, MPH

Deputy Director for Science and Chief Scientist, Director, ODE (Acting), CDRH , FDA , United States

Kathleen E. O'Sullivan, MS, RAC

Kathleen E. O'Sullivan, MS, RAC

Worldwide Director, Regulatory Affairs, BD Medical - Diabetes Care, United States

Edward  Patten, MS

Edward Patten, MS

Associate Director for Manufacturing Science, CBER, FDA, United States

Ibim B. Tariah, PhD

Ibim B. Tariah, PhD

Vice President, EU MDR & IVDR Services, Regulatory & Quality Solutions (R&Q), United States

Dr. Tariah has over 30 years experience in the medical device industry, including 21 years at BSI. In his role of VP of EU MDR and IVDR Consulting Services at R&Q, he provides leadership, strategic advisement and implementation expertise to R&Q's consulting team and clients. Prior to R&Q in his role of Technical Director of Medical Devices for BSI Americas, Dr. Tariah was part of the BSI Americas leadership team responsible for transitioning from MDD to MDR certification. He created and led customized MDD and MDR workshops for clients and industry, and spoke on behalf of the notified body at global conferences and events.

Dave  Anderson

Dave Anderson

Associate Director Quality for Combination Products, AstraZeneca Biologics (MedImmune), United States

Melissa  Burns, MS

Melissa Burns, MS

Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States

CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received 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.

Shannon  Hoste, MS

Shannon Hoste, MS

President, Agilis Consulting Group, United States

Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products. In addition to 20 years in industry as a systems engineer, Shannon also worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA). At the FDA she led reviews of Human Factors data for premarket submissions through 510(k), PMA and De Novo as well as NDA, BLA, ANDA pathways, and IND and IDE requests.

Diane  Maloney, JD

Diane Maloney, JD

Associate Director for Policy, CBER, FDA, United States

Diane Maloney, J.D., is the Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). She oversees regulation and policy development for CBER as well as the Center’s participation on cross-cutting agency initiatives. She has served in this capacity since 2000. Ms. Maloney was formerly Associate Chief Counsel for Drugs and Biologics in FDA's Office of the Chief Counsel (OCC) from 1985 to 2000, focusing on a variety of cross-cutting agency matters, including human subject protection, clinical trials, product approval, and infectious disease issues.

Brenda K. Schultz, MBA, RN

Brenda K. Schultz, MBA, RN

Senior Principal, Strategic Alliance Management, Medtronic, United States

Sandy  Koppenol, PhD, MS

Sandy Koppenol, PhD, MS

Senior Research Scientist II, Gilead Sciences, United States

Willy  Liou, MS, RAC

Willy Liou, MS, RAC

Manager, Regulatory Affairs, Amgen, Inc., United States

Francisco  Vicenty

Francisco Vicenty

Supervisory Consumer Safety, CDRH, FDA, United States

Rakhi  Dalal-Panguluri, PhD

Rakhi Dalal-Panguluri, PhD

Toxicologist, CDRH, FDA, United States

Christopher J. Kurtz

Christopher J. Kurtz

Vice President, Drug Device Industrialization, AbbVie, United States

Douglas C. Throckmorton, MD

Douglas C. Throckmorton, MD

Deputy Center Director for Regulatory Programs CDER, FDA, United States

As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks. Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.

Melissa  Torres, MS

Melissa Torres, MS

Associate Director for International Affairs, CDRH, FDA, United States

James L. Dunnie

James L. Dunnie

Consumer Safety Officer, Office of Regulatory Affairs, FDA, United States

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