Posted: 05 August 2016

2016最新研討會資訊

http://www.raps-in-taiwan.org.tw/apec/index.html

Posted: 25 August 2014

你有看過藥品上面標明"僅限男性服用"嗎?
以往的藥品臨床試驗都是拿男性來作，不拿女的來做是因為女生有生理期懷孕Blabla，會影響實驗數據等等不便。但是藥品對女性的影響便無從得知。
同理，不同年齡與種族也是一個影響因子的隱憂。
FDA於2013 Aug 發布section 907的草稿發現大多數公司有報告臨床試驗性別的差異，但在年齡及種族差異卻仍作的不夠好。而此事件也引起一些立法者的關注，未來可能督促FDA將婦女和少數民族納入臨床試驗的措施。

Edit by Rita,
Reference: Alexander Gaffney, RAPS

想知道更多 歡迎加入RAPS 會員 http://www.raps-in-taiwan.org.tw/

Posted: 10 July 2014

This popular webcast series serves as a study tool for individuals preparing for the RAC (US) Exam. Many candidates use the Fundamentals of US Regulatory Affairs publication to study for the RAC for the recall portion of the exam, but there are few resources that review the exam’s analysis and application components. As such, the “application to the workplace” component is a common thread found throughout the series. RAPS is offering this webcast series designed to expand on the written text through applications and examples that will reveal more than you learned by reading the book. These webcasts are not simply online presentations of selected chapters. Think of Fundamentals as the ABCs and this webcast series as the mechanism to form words and put the strong foundational knowledge to use.

The live webcasts include interactive Q&A sessions with subject matter experts. While the presenters will be covering select topics, attendees can take the opportunity to ask questions to clear up any areas of confusion they encountered when reading the Fundamentals publication.

Recognizing the importance of extended access to increase the likelihood of knowledge retention and behavior change, RAPS is offering registrants free access to the recordings for one year after the date of the live events. These recordings can be accessed at any time, with no restrictions on the number of viewings.