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Prequalification of Medicines for Neglected Tropical Diseases

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
291

Room Number:
30AB

Level:
Basic

Type:
Session

Title:
Prequalification of Medicines for Neglected Tropical Diseases

Chair(s):
Jacqueline M. Kline, PhD
Senior Director Global Regulatory Affairs
Eisai Inc., United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
WHO Perspective
Lembit Rago, MD, PhD
Head, Regulation of Medicines and other Health Technologies
World Health Organization (WHO), Switzerland

Challenges in Registering Products in Low- and Middle-Income Countries and What We Are Trying to Do With Various Partners
Murray M. Lumpkin, MD, MSc
Deputy Director, Regulatory Affairs, Global Health and Integrated Development
Bill and Melinda Gates Foundation, United States

WHO Prequalification of Diethylcarbamazine for Elimination of Lymphatic Filariasis
Jacqueline M. Kline, PhD
Senior Director Global Regulatory Affairs
Eisai Inc., United States