今天由Irene為我們介紹法規部門的業務,
主要為藥品的查驗登記、仿單變更、適應症變更等,
另外還簡介了plant master file和國外查廠。
RA的工作內容較為繁瑣,主要是收集查驗登記等需檢附的資料,
編排後送至tFDA審核,
之後每到一定的期限須更新資料等,
與tFDA及原廠的R業務上往來十分密切,
其他就是翻譯仿單、核對新舊仿單,
看條文收集需要的資料,補件等。
練習了仿單變更查驗登記,
先把英文版新舊仿單逐句對照,
把不同的地方圈出,在將中文版單依照新的英文仿單修改,
再附上tFDA要求的相關資料,
即可送件了,
練習過後大家一致認為,以後應該不會相從事這樣的工作。
2011年7月12日 星期二
2011年7月11日 星期一
Tiago Iorc - Fine
很輕鬆的一首歌。
He's never been lonely
She takes his hand and all his troubles step aside
He's never felt like this before,
But he'd like to try
'Let Yourself in', it's all he's thinking about
'Let Yourself in', now he's singing out loud
I'm feeling like my life has just begun
And I'm feeling fine
I fell so alive, singin'
I'm feeling like my life has just begun
And I'm feeling fine
So fine, fine, fine
She lightens up his morning
All of his plans seem so damn easy to decide
It's not about just feeling lonely
It's more, just give it a try
'Let Yourself in', it's all he's thinking about
'Let Yourself in', now he's singing out loud
I'm feeling like my life has just begun
And I'm feeling fine
I fell so alive, singin'
I'm feeling like my life has just begun
And I'm feeling fine
So fine, fine, fine
I can't wait to find my way home
I can't wait to get to start
It will not be done, until it's all begun
He's never been lonely
She takes his hand and all his troubles step aside
He's never felt like this before,
But he'd like to try
'Let Yourself in', it's all he's thinking about
'Let Yourself in', now he's singing out loud
I'm feeling like my life has just begun
And I'm feeling fine
I fell so alive, singin'
I'm feeling like my life has just begun
And I'm feeling fine
So fine, fine, fine
She lightens up his morning
All of his plans seem so damn easy to decide
It's not about just feeling lonely
It's more, just give it a try
'Let Yourself in', it's all he's thinking about
'Let Yourself in', now he's singing out loud
I'm feeling like my life has just begun
And I'm feeling fine
I fell so alive, singin'
I'm feeling like my life has just begun
And I'm feeling fine
So fine, fine, fine
I can't wait to find my way home
I can't wait to get to start
It will not be done, until it's all begun
Day 6
今天Andrew教我們行銷過程中的最後三個步驟,
計劃→銷售→評估,此三行為總稱作顧客關係管理(customer relationship management,CRM)
中文定義十分複雜,
企業建立完善的資料庫來收集分析客戶的資料,已達成顧客對企業終身價值最大化的所有互動過程。
簡言之,就是我們日常都會接觸的商業行為的互動過程,
例如去店裡購物,店家總是希望妳能成為會員,讓你累積點數,實際上是在收集你的每一筆消費資訊,
利用所累積的訊息,從你口袋挖出最大的利潤。
CRM最重要的是在建立顧客的資料,
不同於其他產業,製藥業屬於封閉的市場,顧客資訊不易取得,
必須靠次要資料推知,因此CRM分析較為困難。
擬定好計畫後,開始執行計劃,
然而資源有限,我們如何將有限的資源分配到目標客戶上並得到最大的價值,
今天practice,我們有十次拜訪醫師的機會,
即十種在拜訪中可以做的行銷策略,
拜訪的對象分別為不常處方我們要務的醫師及有很高比例處方我們藥物的醫師,
對兩種顧客實行的行銷手法不同,達到的目的也不同,
然而資源的分配沒有一定,端看你想達到的目標及公司的狀況。
這多種可能性真是社會科學令人既愛又恨的地方。
另外,了解IRPMA市場處方規範後,
感變了一些我對藥業的想法,
有能力的話,他們也希望朝向以研發為主,達最大利益的永續經營。
計劃→銷售→評估,此三行為總稱作顧客關係管理(customer relationship management,CRM)
中文定義十分複雜,
企業建立完善的資料庫來收集分析客戶的資料,已達成顧客對企業終身價值最大化的所有互動過程。
簡言之,就是我們日常都會接觸的商業行為的互動過程,
例如去店裡購物,店家總是希望妳能成為會員,讓你累積點數,實際上是在收集你的每一筆消費資訊,
利用所累積的訊息,從你口袋挖出最大的利潤。
CRM最重要的是在建立顧客的資料,
不同於其他產業,製藥業屬於封閉的市場,顧客資訊不易取得,
必須靠次要資料推知,因此CRM分析較為困難。
擬定好計畫後,開始執行計劃,
然而資源有限,我們如何將有限的資源分配到目標客戶上並得到最大的價值,
今天practice,我們有十次拜訪醫師的機會,
即十種在拜訪中可以做的行銷策略,
拜訪的對象分別為不常處方我們要務的醫師及有很高比例處方我們藥物的醫師,
對兩種顧客實行的行銷手法不同,達到的目的也不同,
然而資源的分配沒有一定,端看你想達到的目標及公司的狀況。
這多種可能性真是社會科學令人既愛又恨的地方。
另外,了解IRPMA市場處方規範後,
感變了一些我對藥業的想法,
有能力的話,他們也希望朝向以研發為主,達最大利益的永續經營。
2011年7月9日 星期六
You don't know me
Ben Folds and Sara Bareilles - You Don't Know Me
a lovely song :)
I wanna ask you
Do you ever sit and wonder,
It's so strange
That we could be together for
So long, and never know, never care
What goes on in the other one's head?
Things I've felt but I've never said
You said things that I never said
So I'll say something that I should have said long ago:
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
You could have just propped me up on the table like a mannequin
Or a cardboard stand-up and paint me (paint me)
Any face that you wanted me
To be seen.
We're
Damned by the existential moment where
We saw the couple in the coma and
It was we were the cliché,
But we carried on anyway.
So, sure, I could just close my eyes.
Yeah, sure, trace and memorize,
But can you go back once you know
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me
If I'm the person that you think I am (Ah ah ahh)
Clueless chump you seem to think I am (Ah ah ahhh)
So easily led astray,
An errant dog who occasionally escapes and needs a shorter leash, then
Why the f**k would you want me back?!
Maybe it's because
(You don't know me at all)
Ahhh ah
Ahhh ah
(You don't know me,
you don't know me.)
Ahhh ah
Ahhh ah
So, what I'm trying to say is
What (What?)
I'm trying to tell you
It's not gonna come out like I wanna say it cause I know you'll only change it.
(Say it.)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
What?
a lovely song :)
I wanna ask you
Do you ever sit and wonder,
It's so strange
That we could be together for
So long, and never know, never care
What goes on in the other one's head?
Things I've felt but I've never said
You said things that I never said
So I'll say something that I should have said long ago:
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
You could have just propped me up on the table like a mannequin
Or a cardboard stand-up and paint me (paint me)
Any face that you wanted me
To be seen.
We're
Damned by the existential moment where
We saw the couple in the coma and
It was we were the cliché,
But we carried on anyway.
So, sure, I could just close my eyes.
Yeah, sure, trace and memorize,
But can you go back once you know
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me
If I'm the person that you think I am (Ah ah ahh)
Clueless chump you seem to think I am (Ah ah ahhh)
So easily led astray,
An errant dog who occasionally escapes and needs a shorter leash, then
Why the f**k would you want me back?!
Maybe it's because
(You don't know me at all)
Ahhh ah
Ahhh ah
(You don't know me,
you don't know me.)
Ahhh ah
Ahhh ah
So, what I'm trying to say is
What (What?)
I'm trying to tell you
It's not gonna come out like I wanna say it cause I know you'll only change it.
(Say it.)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
(You don't know me)
You don't know me at all
(You don't know me)
You don't know me at all (at all)
What?
基隆廟口
實習結束後和柿子小姐等人,
開啟基隆隨性之旅。
40分鐘的車程來到了碼頭附近,
巨大華麗的麗星郵輪停泊在港灣,
由老伯伯們組成的薩克斯風樂團於沿岸的步行區吹起一首首饒富異國風情的樂曲,
遊客意興闌珊地圍著打起拍子,
一周的忙碌後在港口吹吹風挺舒服的。
過了馬路就是熱鬧的廟口夜市,
主要販賣海產、冰飲及各式麵類,
廟宇旁的攤販不但有清楚邊號還貼心地寫上日文及英文翻譯,
文化交流的現象在台灣各處可見,但在此處又更加鮮明了,
下次有機會,
要帶著底片記錄下族群融合過程中衝突又豐富的景象。
開啟基隆隨性之旅。
40分鐘的車程來到了碼頭附近,
巨大華麗的麗星郵輪停泊在港灣,
由老伯伯們組成的薩克斯風樂團於沿岸的步行區吹起一首首饒富異國風情的樂曲,
遊客意興闌珊地圍著打起拍子,
一周的忙碌後在港口吹吹風挺舒服的。
過了馬路就是熱鬧的廟口夜市,
主要販賣海產、冰飲及各式麵類,
廟宇旁的攤販不但有清楚邊號還貼心地寫上日文及英文翻譯,
文化交流的現象在台灣各處可見,但在此處又更加鮮明了,
下次有機會,
要帶著底片記錄下族群融合過程中衝突又豐富的景象。
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