I had the privilege of visiting the Advanced Drug Quality Division at the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, also known as KFDA. During my visit, I shared my expertise on qualifying container closure systems and detailed the information included in the Common Technical Document (CTD). The discussion was highly engaging, and I received insightful questions. I informed the audience that the US FDA encourages utilizing first principles to understand the product and packaging comprehensively. Additionally, I emphasized the importance of involving packaging engineers in the early phases of drug development and highlighted the critical role of CM&C cross-functional teams in successful drug development. I extend my sincere thanks to Dr. Ko Yongseok, the head of the division, for providing me with this valuable opportunity to engage with your scientists.
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