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Overview

November 10-11: Conference

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.

The DIA’s Complex Generics Conference will examine current knowledge and ongoing scientific research where industry, regulators, and stakeholders dialog on today’s best answers and solutions to key questions regarding the development of complex generic drug-device combination products.

While we work on the agenda for 2022, please view our 2020 Final Program to see the topics presented.

Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. Don’t miss out on your chance to meet live again with your friends and colleagues!

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

Program Committee

  • Rosario  LoBrutto, PhD
    Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs
    Sandoz, United States
  • James  Wabby, MHS
    James Wabby, MHS Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
    AbbVie, Inc., United States
  • Roisin  Wallace
    Roisin Wallace Vice President, Head of Global Device Development
    Viatris, Ireland
  • Quanying  Bao
    Quanying Bao Assistant Research Professor
    University of Connecticut, United States
  • Brandon  Wood
    Brandon Wood Associate Director, Regulatory Affairs
    Teva Pharmaceuticals USA, Inc., United States
  • Sivakumar R Vaithiyalingam, PhD
    Sivakumar R Vaithiyalingam, PhD Principal
    ARK Pharma Services LLC, United States
  • Representative Invited
    Representative Invited DIA, United States
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