Introduction to Australian, Asian, and Latin American Regulatory Affairs

Catalog description

Covers the applicable regulatory agency guidance and GMPs associated with biopharmaceutical and medical device product design, quality assurance, and commercialization specifically in Australia, Asia, and Latin America. 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 government regulations and guidance, as well as the guidance and regulations from the General Agreement on Tariffs and Trade (GATT/WTO).