Vol. 60: 5th Chemistry, Manufacturing&Control Academy Sponsored by Otsuka Korea - a podcast by Otsuka Pharmaceutical Co., Ltd 大塚製薬

Read the full story with photos at:

https://www.otsuka.co.jp/en/company/globalnews/2014/1014_02.html

 

Japanese experts were invited to address key industry issues of Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the developmental trend of biomedicine to provide Korean pharmaceutical companies with helpful information on chemistry, manufacturing and control (CMC) in drug development.

This is the 5th time Korea’s Ministry of Health and Welfare and Otsuka Pharmaceutical have sponsored “Korea Drug Research Academy-OTSUKA CMC ACADEMY”. Each year about 100 trainees attend this program.

This year, Mr. Kunio Kawamura, advisor of Japan’s Otsuka Pharmaceutical, emphasized that the mission of PIC/S was to establish the harmonized global standard in the inspection field work.

He said, “All of the partnered countries would follow uniform guidelines in giving approval, so that they can maintain a high quality of monitoring.”

Companies definitely benefit by joining PIC/S as they reduce duplicated inspection when exporting to multiple countries such as the US and Japan, and, thus, save on related costs.

Mr. Kawamura said, “Member countries should cooperate in order to minimize duplicated inspections. And more countries should join PIC/S, develop information sharing systems and communicate more actively to facilitate imports and exports.”

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