Global Awareness: Canada, Asian, and Latin American Regulatory Affairs
RA3223 / 4 q.h.
Starting with the fall 2009 term, this course will be renumbered as RGA 6223.
This course 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. Students will examine multinational documents from Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), MERCOSUR, and Pan American and World Health Organizations. Latin American governmental regulations and guidances as well as the guidances and regulations from FDA and General Agreement on Tariffs and Trade (GATT/WTO) will be discussed.
There are no current sections scheduled for this course number. Please note that courses have been assigned new numbers beginning with the fall term. Please check the new course number for course availability.
|