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Overview

October 19-20: Conference


Co-sponsored with the FDA.

Complex Generic Drugs are a large and diverse group of products with complex active ingredients or formulations, complex routes of delivery (such as locally acting drugs in dermatological products and complex ophthalmological products), or complex dosage forms (e.g., transdermals or extended release injectables). They also include complex drug-device combination products (such as auto injectors and metered dose inhalers) and other products where complexity or uncertainty concerning the approval pathway or possible alternative development approaches would benefit from early scientific engagement.

Though the products in this diverse collection provide important therapies to patients, their complex elements make them difficult to produce, thus impeding access to the more affordable generic versions of these life-saving medicines.

Since the 2017 announcement of the Drug Competition Action Plan, the FDA has been working to improve the efficiency of the generic drug approval process and make it easier to bring generic competition and improve consumer access to this important category of drugs. In addition to improving regulatory clarity with respect to complex generic products, research collaborations funded through the Generic Drug User Fee Amendments (GDUFA) in 2018 and 2019 have provided data to support assessment and approval of these products.

The DIA/FDA’s Complex Generic Drug-Device Combination Products Conference will examine current knowledge and ongoing scientific research of the FDA Office of Generic Drugs (OGD) supporting evidence-based development, assessment, and approval of complex generic combination products. Join FDA staff and industry experts to discuss these topics, as well as common review issues and challenges, expectations for industry after product approval, and future directions for the development of the generic versions of these important therapeutic products.



Program Now Available!

The program has been released! Preview all session descriptions, speakers, and more all in one place!

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Who should attend?

Professionals involved in:

  • Biopharmaceutical, Device, and Combination Product R&D and Development
  • Generics Development
  • Clinical Research
  • Pharmacology
  • Regulatory Affairs
  • Safety/Pharmacovigilance
  • Quality Assurance and Control
  • CMC/GMP
  • Policy
  • Consulting, Legal, Government Affairs
  • Business Development

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Explore the statutory framework, and associated regulatory and policy considerations, for drug-device combination products submitted in an ANDA
  • Identify and address scientific considerations for establishing bioequivalence for different complex generic drug-device combination delivery methods
  • Identify specific product quality considerations and challenges in developing different approaches to complex generic drug-device combination product manufacturing
  • Discuss ideas for improving communication and collaboration between industry, academia and the agency in developing novel methods and standards for assessing the sameness of complex generic drug-device combination products.
  • Explore the challenges and opportunities in post-marketing pharmacovigilance and lifecycle management for complex generic drug-device combination products

Program Committee

  • Karthik  Balasubramanian, PhD, MS
    Karthik Balasubramanian, PhD, MS Director, Combination Products and Semisolids, Generic CPD
    Teva Pharmaceuticals, United States
  • Lisa  Bercu, JD
    Lisa Bercu, JD Regulatory Counsel, Office of Generic Drugs Policy
    FDA, United States
  • Howard  Chazin, MD, MBA
    Howard Chazin, MD, MBA Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, 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, CSSS, Office of Generic Drugs, CDER
    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 Project Manager, OGD, IO
    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 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
    Sarah Mollo, 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 Executive Director, Regulatory Affairs, Emerging Technologies and CMC - Device
    AbbVie, United States
  • Roisin  Wallace
    Roisin Wallace Vice President, Head of Global Device Development
    Mylan, 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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