C******d
发帖数: 40 | 1 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？ |
o*******e
发帖数: 238 | |
s**********8
发帖数: 25265 | 3 有实战经验吗? 有实战经验, 那都是一层窗户纸, 每啥技术含量. 没实战经验就花钱买
培训webcast.
【在 C******d 的大作中提到】
: 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
: 的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
: 在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？
|
C******d
发帖数: 40 | 4 有药物方面的一点经验，想通过这个考试延伸到其他相关领域，比如device等。
【在 s**********8 的大作中提到】
: 有实战经验吗? 有实战经验, 那都是一层窗户纸, 每啥技术含量. 没实战经验就花钱买
: 培训webcast.
|
s**********8
发帖数: 25265 | 5 有实战经验应该不难, 难得是赞系统知识, RA是个后继播发的领域. 最好从R&D干上来,
会很得心应手.
【在 C******d 的大作中提到】
: 有药物方面的一点经验，想通过这个考试延伸到其他相关领域，比如device等。
|
n*******n
发帖数: 515 | 6 就买它官方的那本书，现在已经是第七版了，一两百块吧，读三遍，然后买模拟题，八
九十块，做几遍。我是这样考过的
【在 C******d 的大作中提到】
: 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
: 的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
: 在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？
|
C******d
发帖数: 40 | 7 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？ |
o*******e
发帖数: 238 | |
|
s**********8
发帖数: 25265 | 9 有实战经验吗? 有实战经验, 那都是一层窗户纸, 每啥技术含量. 没实战经验就花钱买
培训webcast.
【在 C******d 的大作中提到】
: 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
: 的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
: 在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？
|
C******d
发帖数: 40 | 10 有药物方面的一点经验，想通过这个考试延伸到其他相关领域，比如device等。
【在 s**********8 的大作中提到】
: 有实战经验吗? 有实战经验, 那都是一层窗户纸, 每啥技术含量. 没实战经验就花钱买
: 培训webcast.
|
|
|
s**********8
发帖数: 25265 | 11 有实战经验应该不难, 难得是赞系统知识, RA是个后继播发的领域. 最好从R&D干上来,
会很得心应手.
【在 C******d 的大作中提到】
: 有药物方面的一点经验，想通过这个考试延伸到其他相关领域，比如device等。
|
n*******n
发帖数: 515 | 12 就买它官方的那本书，现在已经是第七版了，一两百块吧，读三遍，然后买模拟题，八
九十块，做几遍。我是这样考过的
【在 C******d 的大作中提到】
: 我就是闲得蛋疼，也没指望用它找工作什么的，至少不是立刻去找。想问问哪里有简单
: 的入门攻略吗？比如看什么书，需要准备多久？我一头雾水，不知道从哪里开始。
: 在版上search了一下，好像有本红宝书要读。还有别的吗？有没有前辈介绍一下呢？
|
s******e
发帖数: 370 | 13 在raps网站上看这本Fundamentals of US Regulatory Affairs现在已经到第8版了，而
且价钱是300多……
【在 n*******n 的大作中提到】
: 就买它官方的那本书，现在已经是第七版了，一两百块吧，读三遍，然后买模拟题，八
: 九十块，做几遍。我是这样考过的
|
h**********8
发帖数: 650 | |
t*********1
发帖数: 2852 | |
j******w
发帖数: 97 | 16 Join RAPS (you will have to pay for the membership anyway when you register
for the exam - this may have changed though.)
Join a local RAC exam study group. Call for study group is usually posted on
the RAPS local chapter mailing list.
Get the book "Fundamental of US regulatory affairs" from RAPS.
FDA offers a lot of free training materials.
See here http://www.fda.gov/Training/default.htm
Many people have passed the exam with little or no experience. I think the
passing score is 75% percentile. |
j****w
发帖数: 756 | 17 谢谢，非常详细。
做质量控制和R&D多年，有这个证是不是就可以做申报工作了?
更多的工作机会？
register
on
【在 j******w 的大作中提到】
: Join RAPS (you will have to pay for the membership anyway when you register
: for the exam - this may have changed though.)
: Join a local RAC exam study group. Call for study group is usually posted on
: the RAPS local chapter mailing list.
: Get the book "Fundamental of US regulatory affairs" from RAPS.
: FDA offers a lot of free training materials.
: See here http://www.fda.gov/Training/default.htm
: Many people have passed the exam with little or no experience. I think the
: passing score is 75% percentile.
|
C******d
发帖数: 40 | 18 Thanks a lot!
register
on
【在 j******w 的大作中提到】
: Join RAPS (you will have to pay for the membership anyway when you register
: for the exam - this may have changed though.)
: Join a local RAC exam study group. Call for study group is usually posted on
: the RAPS local chapter mailing list.
: Get the book "Fundamental of US regulatory affairs" from RAPS.
: FDA offers a lot of free training materials.
: See here http://www.fda.gov/Training/default.htm
: Many people have passed the exam with little or no experience. I think the
: passing score is 75% percentile.
|
j******w
发帖数: 97 | 19 If I had to be a little pessimistic, a RAC certificate provides very little
benefit on how well you do in regulatory. The reason is simple, the
knowledge one gains from studying for the RAC exam is broad (in my opinion
unnecessarily broad), and at too high a level. It does not represent what
one
encounters in a real RA job. If one already knows which area of RA to
venture in, CMC, submission, clinical, labeling, ad/prom, operations, it is
much more helpful for one to read the guidance and study the training
materials available from FDA.
The only benefit of a RAC certificate I can think of is to show your
interest in, and intent and efforts to pursue a career in RA. I used to
think it may be considered part of a candidate's qualification. But from
what I have seen so far, it bears very little weight on a hiring decision.
It is 锦上添花 for those who would be hired anyway.
That being said and seeing how difficult it is to land the first job in RA,
I personally still think RA is, at this moment, a fair good job option for
people with a R&D background as technical and scientific knowledge usually
comes in handy in a RA job. On the CMC side, a scientific background can be
a huge advantage. Critical thinking (most of time being logical is more than
enough), writing skills from "publishing watering" and presentation skills
are all big contributors to succeeding in RA.
【在 j****w 的大作中提到】
: 谢谢，非常详细。
: 做质量控制和R&D多年，有这个证是不是就可以做申报工作了?
: 更多的工作机会？
:
: register
: on
|
s**********8
发帖数: 25265 | 20 机会总是啥准备的头脑不是. 我送一些免费的RAC学习资料, 女ID优先.
little
is
【在 j******w 的大作中提到】
: If I had to be a little pessimistic, a RAC certificate provides very little
: benefit on how well you do in regulatory. The reason is simple, the
: knowledge one gains from studying for the RAC exam is broad (in my opinion
: unnecessarily broad), and at too high a level. It does not represent what
: one
: encounters in a real RA job. If one already knows which area of RA to
: venture in, CMC, submission, clinical, labeling, ad/prom, operations, it is
: much more helpful for one to read the guidance and study the training
: materials available from FDA.
: The only benefit of a RAC certificate I can think of is to show your
|
m**5
发帖数: 729 | 21 very well said
little
is
【在 j******w 的大作中提到】
: If I had to be a little pessimistic, a RAC certificate provides very little
: benefit on how well you do in regulatory. The reason is simple, the
: knowledge one gains from studying for the RAC exam is broad (in my opinion
: unnecessarily broad), and at too high a level. It does not represent what
: one
: encounters in a real RA job. If one already knows which area of RA to
: venture in, CMC, submission, clinical, labeling, ad/prom, operations, it is
: much more helpful for one to read the guidance and study the training
: materials available from FDA.
: The only benefit of a RAC certificate I can think of is to show your
|
