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243718 My practicum experience at the World Health OrganizationTuesday, November 1, 2011: 10:30 AM
Introduction: This presentation is on the practicum I undertook with the World Health Organization as part of my MPH requirements. I analyzed the regulatory section of a pharmaceutical profile survey on 12 countries (Argentina, Armenia, Austria, China, Jordan, Kenya, Maldives, Nigeria, Pakistan, Sri Lanka, Sudan and Suriname) and drew generic conclusions from which other countries and policy makers could learn. Method: I reviewed the study questionnaire and other documents submitted by the study countries. In addition, I searched the websites of the Medicines Regulatory Authorities for supplementary information. I evaluated the following legal and administrative provisions on pharmaceutical regulation: regulatory framework and capacity, marketing authorization, licensing of premises, import control, regulatory inspection, medicines advertisement and promotion, controlled substances, market control and quality control, clinical trial, and pharmacovigilance. Results: Compared to the other regulatory functions, pharmacovigilance and clinical trials were less governed by legislations. More countries had legal provisions on Good Manufacturing Practice (GMP) than on Good Distribution Practice (GDP). Legal provisions that promote transparency, e.g. those requiring the publishing documents such as GMP and GDP requirements, the list of registered pharmaceutical products, quality testing results etc. were less common. Benefits: Interning with the WHO has enabled me to develop a strong network with senior public health officials. It provided me with the opportunity to put into practice the classroom lessons I learned at Boston University. Through my practicum project I developed interest in pharmaceutical regulation, an area I would like to establish as the premises of my career.
Learning Areas:
Public health or related educationPublic health or related laws, regulations, standards, or guidelines Learning Objectives: Keywords: Practice, International Health
Presenting author's disclosure statement:
Qualified on the content I am responsible for because: I worked on this project in fulfillment of the practicum requirement for my MPH degree. I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.
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