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: 1 July 2014

This fall, the?Regulatory Affairs Professionals Society?(RAPS) invites you to command the respect of your peers and establish your value in the industry by earning the?Regulatory Affairs Certification?(RAC) credential. This professional credential is the only globally recognized certification for the regulatory profession.

Benefits for You:

• Illustrates your regulatory proficiency
• Highlights your professional and personal accomplishments in regulatory affairs
• Encourages continuous career development through credential maintenance
• Promotes career longevity and advancement through continued skill development
• Secures greater earning potential (RAC holders earn an average of 10% more?than those without the credential)

Benefits for Your Employer:

• Validates your employee’s professional competence in the regulatory field
• Promotes ongoing professional development through credential maintenance
• Encourages development of a more productive and highly trained workforce

Apply by 1 September for the Fall Exam Cycle (October-November)

• Find Out More
• Download the Candidate's Guide
• Apply
• Prepare