Slides used at CPhI JAPAN 2013
資 料 標 題
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日本における薬事手続きの注意点
Points to Note in Relation to Pharmaceutical Regulatory Procedures in Japan
MF制度とその留意事項
The Master File System and Points to Consider
GMP適合性調査の指摘事項と問題点(製造業者/製造販売業者/MF国内管理人等)
Examples of Observations in GMP Compliance Inspections,and Related Problems
製造販売業者から外国製造業者に望むこと
What Marketing Authorization Holders are Looking for in Foreign Manufacturers for a Stable Supply