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USFDA–CDSCO-DIA: “Workshop on Global Anti-Infective Drug Development: Challenges and Opportunities”

Learn from regulatory (USFDA, CDSCO) and Industry experts on Drug Development of Anti- Infectives


Overview

Antimicrobial resistance (AMR) is one of the major threats to human health in the 21st century, with some bacterial pathogens acquiring resistance to all clinically available antibiotics. Worldwide, infections caused by multi-drug resistant (MDR) bacteria are now a major cause of morbidity & mortality and have markedly enhanced healthcare costs.

The workshop presents a unique opportunity to hear directly from the regulatory and subject matter experts working on Drug Development of Anti-Infectives.

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Who should attend?

  • Clinical research professionals
  • Pharmaceutical Experts working in novel drug development, clinical design and strategy
  • Academicians engaged in research

    Learning objectives

    • Hear and learn about the regulatory approach and the science behind the development of anti-infectives through actual case studies shared by the USFDA’s experts from the Department of anti-infective products.
    • Explore the possibilities of synergies that can be leveraged in your own drug development programs through this Workshop

    Program Committee

    • Edward M.  Cox, MD, MPH
      Edward M. Cox, MD, MPH Vice President, Regulatory Affairs
      Regfeneron, United States
    • Sumathi  Nambiar, MD, MPH
      Sumathi Nambiar, MD, MPH Senior Director, Child Health and Innovation Leadership Department
      Johnson & Johnson, United States
    • Anand  Eswaraiah
      Anand Eswaraiah Head, Medical and Regulatory Affairs
      Syngene International, India
    • Sudheendra  Kulkarni
      Sudheendra Kulkarni Medical Product Safety Coordinator
      FDA, India
    • Kristan  Callahan
      Kristan Callahan International Relations Specialist
      U.S. Food and Drug Administration, India
    • Anupama  Ramkumar
      Anupama Ramkumar Principal Consultant & CEO
      Arkus Research, India
    • Chandana  Pal
      Chandana Pal Accreditation & Quality Systmes Incharge
      Apollo Research & Innovations (ARI), India
    • Srikanth  Tripathy
      Srikanth Tripathy Director in Charge
      National Institute for Research in Tuberculosis, India
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