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RAC考試 中文線上課程
本課程特選美國醫療法規學會(RAPS)之Regulatory Affairs Certification(GS):Basic教材為基礎,帶領學員了解深入醫藥醫材法規,幫助台灣生醫產業進入國際。

課程費用:4200元 (RAPS台灣分會會員享優惠價4000元)
上課時數:12小時
上課時間:線上學習,一個月內無限次觀看
※ 本課程為Regulatory Affairs Certification(GS) 基礎課程
※ 線上課程恕不提供紙本講義
※ 請使用IE開啟線上課程

諮詢專線:(03)5623116#3231 yhhuang@tcfst.org.tw


課程大綱
1.Fundamentals of International Regulatory Affairs
a.introduction to regulatory affairs
b.premarket requirement/dossier requirements
c.authorization procedures for medicinal products
d.quality systems and inspectorate process-pharmaceuticals
e.pharmaceutical postmarketing and compliance
f.high-risk products derived from biotechnology
g.generic drug products and biosimilars
h.principles of orphan drugs
i.food supplements and cosmetic products
j.veterinary medicinal products
k.over-the-counter products (OTCs)
l.medical device premarket requirements
m.technical and regulatory requirements for medical devices
n.postmarket requirements for medical devices
o.in vitro diagnostic medical devices
p.advertising and promotion
q.compliance and enforcement
2.RAC(GS) practice exam