Northeastern University College of Professional Studies
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Global Awareness: Canada, Asian, and Latin American Regulatory Affairs

RGA6223 / 4 q.h.
Formerly RA 3223.

Covers the Common Technical Documents; General Guidance and GMPs; Global Harmonization Task Force documents; and regulatory affairs dealing with drugs, medical devices, biologics, and natural products. Examines multinational documents from Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), MERCOSUR, and Pan American and World Health Organizations. Discusses Latin American governmental regulations and guidance, as well as the guidance and regulations from FDA and General Agreement on Tariffs and Trade (GATT/WTO).

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