課程介紹

此堂課主要介紹藥廠的法規部門,以及藥事法規專職人員的角色與職務、重要利害關係人,與法規人員在新藥研發過程中所扮演的角色。課程並包含法規人員所需的專業訓練、軟性技能等。希望學員們可以藉由參與這個課程,了解藥廠法規部門的實務運作,並再就學員個人之興趣領域,進一步修習醫藥法規基礎課程與法規進階課程。
This lecture will introduce regulatory affair department, the department functions and the roles in regulatory affairs, stakeholders with RA, and the role in the pharmaceutical R&D. The course also included RA required training, soft skills etc. Through the participation in this lecture, it would expect the participants could understand the regulatory affair department; therefore, participants could explore personal interests and further participant the regulatory affair basics and advanced programs to get the professional knowledge.