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Virtual Event

Oct 19, 2020 10:00 AM - Oct 20, 2020 6:55 PM

Fort Washington, PA 19034

DIA/FDA Complex Generic Drug-Device Combination Products Conference

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Highlights & Features

Program Committee

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

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