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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


Faculty

  • Nilima  Kshirsagar

    Nilima Kshirsagar

    • National Chair Clinical Pharmacology
    • ICMR, India

    Dr Kshirsagar was former acting Vice-Chancellor at the State Health Science University, and also Dean Director of medical education and research, and Prof. Head Clinical Pharmacology G.S. Medical College KEM hospital, Parel, Mumbai and at T. N. Medical College Mumbai, President of the Indian Pharmacology Society and Infectious Disease Society, India, Chairman Academic Committee AIIMS. Govt. of India, Delhi.She has won many awards besides being an University topper, gold medalist, B.C. Roy National Award, Vasvik Award for industrial research, developing and patenting liposomal drug delivery system, Mayor’s award three times.

  • Edward M.  Cox, MD, MPH

    Edward M. Cox, MD, MPH

    • Vice President, Regulatory Affairs
    • Regfeneron, United States

    I am currently Vice President, Regulatory Affairs, at Regeneron Pharmaceuticals in Tarrytown, NY. I am trained in internal medicine and infectious diseases. I have over 20 years of experience at the US FDA, including 12 years as the Director of the Office of Antimicrobial Products, an Office of approximately 150 people.

  • 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

  • P.B.N.  Prasad

    P.B.N. Prasad

    • Deputy Drugs Controller
    • CDSCO West Zone, India

  • Sudheendra  Kulkarni

    Sudheendra Kulkarni

    • Medical Product Safety Coordinator
    • FDA, India

    Dr. Sudheendra is the Medical Product Safety Coordinator for BIMO and Medical Devices. Prior to joining USFDA India office, Sudheendra worked for a leading Contract Research Organization in India as Head – Quality Assurance [GCP]. He has about 18 years of experience in Clinical Research, Quality Assurance, and Quality Management Systems. He has audited more than 500+ Bioequivalence Studies and conducted site audits of different therapeutic drugs that were involved in conducting BEQ studies in Patients, Phase I to Phase III Clinical Trials in patients. He also is experienced in hosting inspections for different regulatory agencies such as USFDA, EMA, ANIVSA, Malaysia, Thailand.

  • Kristan  Callahan

    Kristan Callahan

    • International Relations Specialist
    • U.S. Food and Drug Administration, India

  • Kamini  Walia

    Kamini Walia

    • Senior Scientist
    • ICMR, India

  • Kavita   Singh

    Kavita Singh

    • Mission Director -PMU National Biopharma Mission
    • BIRAC, India

  • Anupama  Ramkumar

    Anupama Ramkumar

    • Principal Consultant & CEO
    • Arkus Research, India

    A Clinician and Researcher, Dr Anupama Ramkumar is the principal consultant and CEO of Arkus Research Pvt. Ltd, a clinical consulting company engaged with pharmaceutical companies and CROs worldwide.With over 26 years of medical experience and 22 years of experience in Clinical Research Industry she bridges the field of medicine and pharmacology effectively and is a sought after clinical development and GCP expert as well as technical strategy advisor for pharma companies and research units. Her forte lies in demystifying GCP to build practical and effective Quality management systems for regulated drug development with a focus on compliance and operational excellence.

  • V  Balasubramanian

    V Balasubramanian

    • Co-Founder & Director
    • Bugworks Research India Pvt. Ltd., India

  • Mahesh  Patel

    Mahesh Patel

    • Director Drug Discovery Research
    • Wockhardt , 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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