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First pharmacy law guidebook by KFDA official
by Eui Kyoung Yoon (ekyeun@dreamdrug.com)
Published : Jul 29, 2012 08:10:13
The first guidebook on pharmacy law was recently published. The author is Chang Byung Kwan, planner and adjuster of the Korea Food and Drug Administration.

Chang is not a pharmacist. Chang said in an interview with Dailypharm, “I had to know about pharmacy law as director of medical product safety department, but I didn’t have any good guidebook. That was the first time when I thought somebody had to publish a pharmacy law guidebook for those who are not pharmacists.”

It wasn’t easy to write the guidebook. Chang said, “The existing pharmacy law books were too professional for a layperson to understand. It took a long time for me to understand pharmacy law correctly and rewrite them in easy words.”

He spent two to three days weekly writing the guidebook which differentiates from existing straight law books.

Chang said, “I focus on the life cycle of a drug. New drug development, marketing approval, distribution and post-market surveillance were matched with actual pharmacy law and regulations.”

Chang has been a government official for thirty years. He said he got helped by other KFDA officials, adding that he could add some definitions and actual cases to his book.

Chang said, “I wish my book will help new employees of KFDA and pharmacy students who want to know pharmacy law.”
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