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