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Regulatory Affairs - DevelopmentDESCRIPTION
Regulatory Affairs - Development. Wednesday, June 30, 2010. Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development. Differences between EMEA and FDA Regulations. Coordination Between GMPs and GCPs. In Europe, GMPs and GCPs are much more closely associated and inter-related than in the US, where they are usually considered as two separate and independent regulations. One has only to examine section 5.14 of the ICH E6 Good Clinical Practice Guideline. Guidance documen.CONTENT
This web page rahul-regulatoryaffairs.blogspot.com states the following, "Wednesday, June 30, 2010." We saw that the webpage said " Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development." It also said " Differences between EMEA and FDA Regulations. Coordination Between GMPs and GCPs. In Europe, GMPs and GCPs are much more closely associated and inter-related than in the US, where they are usually considered as two separate and independent regulations. One has only to examine section 5. 14 of the ICH E6 Good Clinical Practice Guideline."