Clinical Trial, Project Manage and Life.
Clinical Trial for me. It's More Than a Job, It's a Career! Go out of your comfort zone.
When you don't give up, YOU CANNOT FAIL!
"All I ask is one thing... Please do not be cynical. I hate cynicism. For the record, it's my least favorite quality. It doesn't lead anywhere. Nobody in life gets exactly what they thought they were going to get. But if you work really hard and you're kind, amazing things will happen." - Conan O'Brien's final monologue
“Don’t ever let somebody tell you…you can’t do something. You got a dream..you gotta protect it. People can’t do something themselves..they wanna tell you you can’t do it. If you want something go get it“.
2013年7月14日 星期日
2013年6月18日 星期二
「新療效複方新藥」用詞定義
藥事法第七條所稱的新藥,係指經中央衛生主管機關審查認定屬新成分、新療效複方或新使用途徑製劑之藥品。
12月7日發布的行政院衛生署令(發文字號:署授食字第1011102486號)「修正「藥事法施行細則」部分條文」第二條中,「新療效複方新藥」用詞定義為「已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能,或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。」
相較舊詞定義「指已核准藥品具有新醫療效能,或兩種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者」,更加清楚地描述「新醫療效能」的範疇,舉凡「新適應症」、「降低副作用」、「改善療效強度」、「改善療效時間」或「改變使用劑量」皆是,方便於實務遂行。
參考資料:
※轉載自PST – 國際交流暨資訊學習網
2013年6月4日 星期二
2013年5月9日 星期四
Local CRO in Taiwan
前陣子有位韓國的朋友因工作需求,經由此BLOG寄信問我台灣有哪些本土的CRO公司,為此特地整理了一份清單給他,既然整理完了,乾脆就放上來給有需要的人做參考。裡面有很多大家都沒聽過的公司在內,但不用懷疑,他們還是真正的CRO公司,只是很少聽到而已,因為這些公司可能得真正在臨床試驗領域的人才會去接觸到。
1. Global CRO.
2. Taiwan Local CRO
2. BA/BE Study CRO
1. Global CRO.
- 百瑞精鼎 (PAREXEL)
- 華鼎
- 維州 (http://www.vcro.com.tw/)
- 晉加
- 佳生
- 明生
- 全面顧問 (SMO) (http://www.518.com.tw/job-comp_detail-1075340.html) (http://www.ttmc.com.tw/)
2. BA/BE Study CRO
- 明生
- 佳生
- 維州
- 世宬 (BE & phase I)
- 怡發
- 昌達 (http://www.qps.com/)
3. 兩岸醫材 CRO
Clinical Trial Assistant 兼任 CRC的生活。
雖然自己有了130多小時的GCP,也在藥廠做過CRA去送審計畫、專案管理、以及拜訪醫師打通關等等,但一直都沒有機會體會實際收案的狀況。
在今年尋覓CRA工作還未有消息前,剛好國防有個CTA兼任CRC的職務,就很快的答應去面試也獲得錄用,雖然目前才經過一個月,很忙碌但卻很快樂,說也奇怪,若想要有條理的說明對臨床試驗的工作為什麼感興趣,實在是很難說清楚講明白,但為了一堆paper work或是做24小時PK實驗,得7點到辦公室,8.9點才離開辦公室卻也不會覺得心不甘情不願(被老婆看到會被罵死....都不用理老婆了),有興趣這件事,真的很奇妙。
不過目前比較累人的是,一個人要負責8間醫院的收案,希望等自己時間滿檔之後,老闆願意讓我請全職的CRC,也希望將來的CRC能有好表現。
在今年尋覓CRA工作還未有消息前,剛好國防有個CTA兼任CRC的職務,就很快的答應去面試也獲得錄用,雖然目前才經過一個月,很忙碌但卻很快樂,說也奇怪,若想要有條理的說明對臨床試驗的工作為什麼感興趣,實在是很難說清楚講明白,但為了一堆paper work或是做24小時PK實驗,得7點到辦公室,8.9點才離開辦公室卻也不會覺得心不甘情不願(被老婆看到會被罵死....都不用理老婆了),有興趣這件事,真的很奇妙。
不過目前比較累人的是,一個人要負責8間醫院的收案,希望等自己時間滿檔之後,老闆願意讓我請全職的CRC,也希望將來的CRC能有好表現。
2013年1月23日 星期三
Suits S01E03 MEMO
The dinner party is a classic, if overused, plot point in TV programming. Dating back to at least the 1950s in programs like the "Leave it to Beaver" episode "Teacher Comes to Dinner," the dinner party has also been a focal point in episodes of "Seinfeld," "The Vampire Diaries," "Family Guy," and "Married with Children." Most often, the dinner party is high stakes for the main characters because a boss, teacher, or other authority figure will be present. The trope has become so entrenched in pop culture that there is even a reality game show called "The Boss is Coming to Dinner" that forces job applicants to impress a potential boss in order to move up the corporate ladder.
2013年1月4日 星期五
Plan On It: 4 Goals You Should Have For 2013, And How To Get There
Plan On It: 4 Goals You Should Have For 2013, And How To Get There
by John Paul Catanzaro Jan 03, 2013
Strength athletes are creatures of habit. They do the same thing day in and day out: go to the gym, lift things, put them down, go to work, go home. Ingest this much of that macro before you do the other thing. Along the way, they get big, they get strong, and sometimes they get bored.
So how do you cure boredom? Set a challenge! Just for something different, forget about adding more weight to the bar. In fact, forget the bar altogether. Set a challenge that involves only your body weight. It will work your upper body, lower body, and core, and increases your muscular endurance along the way.
Endurance? Don't scoff. Life is not always about a quickie, and we're not talking about running a marathon here. If you accomplish these four strength-endurance goals by the end of the year, you can expect a leaner body, added muscle mass, and improved low-back health for your efforts.
The challenge has been set!
Rising Star: Fitness Model Jeff Seid Talks With Simplyshredded.com Quick Stats:
Rising Star: Fitness Model Jeff Seid Talks With Simplyshredded.com
Quick Stats:
Age: 18
Height: 6’0 – 183 cm
Weight: 185 lbs. 84 kgs
WBFF Bikini Pro Laura Michelle Prestin Talks Simplyshredded.com
WBFF Bikini Pro Laura Michelle Prestin Talks Simplyshredded.com [Updated 2012]
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