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Course on International Regulatory Affairs

Dr. Mel Dong, the President of Blue Bell Consulting, was invited by Johns Hopkins University on November, 15, 2007 (EST) to give a lecture for graduate students of JHU on the topic of “GMP Compliance Worldwide: East-West Comparison.”...

Dr. Mel Dong, the President of Blue Bell Consulting, was invited by Johns Hopkins University on November, 15, 2007 (EST) to give a lecture for graduate students of JHU on the topic of “GMP Compliance Worldwide: East-West Comparison.”

Established in 1876, Johns Hopkins University has been a prominent institution among universities throughout the U.S., dedicating itself with an exceptional reputation in the academic field. Along with the school of medicine as one of the best in the country, the department of biological science is also one of the leading divisions at JHU. Biological science related majors, including but not limited to biological engineering, chemistry, and biological chemistry, have been relatively prominent in the U.S.

“GMP Compliance Worldwide: East-West Comparison” is an important topic under the “International Regulatory Affairs” course. Dr. Mel Dong lectured on the current status of worldwide GMP compliance, including GMP history around the world, driving forces for harmonization, challenges of harmonization, as well as some examples of technical differences and influences.