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Prequalification of Medicines for Neglected Tropical Diseases
Session Chair(s)
Jackie Kline, PHD
Vice President, Global Regulatory Affairs Oncology, Amgen, United States
More than one billion people in developing countries suffer from neglected tropical diseases (NTDs) that cause immense human suffering and death. Safe and effective treatments and control methods are available to fight some NTDs, however, delivering the interventions to poor and hard-to-reach communities in developing countries where people have little access to healthcare is a formidable challenge. In this session, efforts on the part of the World Health Organization (WHO) and the Bill and Melinda Gates Foundation to control, eliminate, or even eradicate NTDs will be discussed. In addition, the successful prequalification of diethylcarbamazine (DEC) for use in the elimination of lymphatic filariasis through the WHO Prequalification of Medicines Programme will be described.
Learning Objective : Discuss neglected tropical diseases including the serious health problems and economic burdens associated with these diseases; Identify the efforts of WHO and the Bill and Melinda Gates Foundation to control, eliminate, and eradicate these diseases; Describe the WHO Prequalification of Medicines Programme; Explain a recent example of the prequalification of diethylcarbamazine (DEC) for elimination of lymphatic filariasis.
Speaker(s)
Lembit Rago, DrMed, MD, PHD
Secretary General, Council for International Organizations of Medical Sciences (CIOMS), Switzerland
WHO Perspective
Murray M. Lumpkin, DrMed, MD, MSC
Deputy Director, Integrated Development, Lead for Global Reg Systems Initiative , Bill and Melinda Gates Foundation, United States
Challenges in Registering Products in Low- and Middle-Income Countries and What We Are Trying to Do With Various Partners
Jackie Kline, PHD
Vice President, Global Regulatory Affairs Oncology, Amgen, United States
WHO Prequalification of Diethylcarbamazine for Elimination of Lymphatic Filariasis
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