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Want to learn more about DIA/FDA Complex Generic Drug-Device Combination Products Conference? You've come to the right site!
Program Committee
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Karthik Balasubramanian, PhD, MS VIce President, CMC & Technical Operations
Verrica Pharmaceuticals, United States -
Lisa Bercu, JD Regulatory Counsel, Office of Generic Drug Policy
FDA, United States -
Howard Chazin, MD, MBA Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
FDA, United States -
William Chong, MD Associate Director for Clinical Affairs, Office of Generic Drugs, CDER
FDA, United States -
Denise Conti, PhD, MSc Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER
FDA, United States -
Karen Feibus, DrMed, MD Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf
FDA, United States -
Andrew Fine, PharmD Clinical Team Leader, Office of Generic Drugs
FDA, United States -
Shahreen Farah Hussain-Malik, MD, MPH Medical Officer
FDA, United States -
Tu-Van Lambert, MS, RAC Regulatory Health Project Manager, OGD, OSCE, DCSS
FDA, United States -
Susan Levine, JD Deputy Director, Division of Policy Development, OGD, CDER
FDA, United States -
Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs
Sandoz, United States -
Patricia Love, MD, MBA Deputy Director, Office of Combination Products, OCPP, OC
FDA, United States -
Markham Luke, MD, PhD Director for Therapeutic Performance, Office of Generic Drugs, CDER
FDA, United States -
Mishale Mistry, PharmD, MPH Associate Director, DMEPA, CDER
FDA, United States -
Sarah Mollo, PhD, RAC, PhD, RAC Combination Product Policy Analyst, OPEQ, CDRH
FDA, United States -
Jordana O'Grady, MA Director, Office of Communications, OGD, CDER
FDA, United States -
Bhagwant Rege, PhD Director, Division of Immediate and Modified Release Products III, OLDP,OPQ, CDE
FDA, United States -
Jason D. Rodriguez, PhD Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis
FDA, United States -
James Wabby, MHS Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States -
Roisin Wallace Vice President, Head of Global Device Development and Operations
Viatris, Ireland -
Kimberly A. Witzmann, MD Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER
FDA, United States -
Rumi Young, MS Acting Team Lead, Combination Products
FDA, United States
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