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全部话题 - 话题: ectd
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s**********8
发帖数: 25265
s**********8
发帖数: 25265
l********r
发帖数: 109
3
来自主题: Pharmaceutical版 - 有人懂CMC regulatory 么?
eCTD (CMC is mainly in M2, M3 I think)
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
http://www.fda.gov/cder/regulatory/ersr/5640CTOC-v1.2.pdf
If you change sth on the licensed process then you need update/inform
agencies:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=601.12
A good course for you:
http://www.ibclifesciences.com/C2025/6018.xml
N****n
发帖数: 1208
4
【 以下文字转载自 Statistics 讨论区 】
发信人: NYHuan (无敌小欢), 信区: Statistics
标 题: 帮朋友发个国内职位(背联系我 ~~~)
发信站: BBS 未名空间站 (Fri Mar 11 03:05:50 2011, 美东)
Job Title
Director, Biostatistics
Region
Asia Pacific
Key Roles
• The Director contributes to and leads strategic initiatives for
the structure and development of the Biostatistics department in order to
achieve the overall goals and mission of company.
• The Director is responsible for managing a team of Statisticians
or Managers who themselves ... 阅读全帖
P***B
发帖数: 1
5
有兴趣的朋友请联系:
黄凯 (Kerwin) ,国内电话:028-86703680, 1355832040, 美国电话:2156352297
邮箱:[email protected]
/* */
--------------------------------职位一 -----------------------------------
【Job Description – Associate Director, Regulatory Affairs】
====Reporting to Executive Director of Regulatory Affairs, the incumbent
will be responsible for outlining the regulatory strategy, coordinate
activities related to regulatory interactions, such as global regulatory
filing, meetings, etc.
====Responsibilities:
Ac... 阅读全帖
N*****m
发帖数: 42603
6
来自主题: Programming版 - Cassandra Rewritten In C++, Ten Times Faster
C*和Riak不能算问题,本来就是eventually consistent
Riak如果把allow-mult打开,是可以保证strong consistency的
另外,ectd和consul也没有问题

maybe-
N*****m
发帖数: 42603
7
来自主题: Programming版 - Consistency做好了不容易
paxos, raft还是可以保证的
ectd是老中写的,不知道上不上本版

log
h*******o
发帖数: 4884
8
I totally agree with you.
The ultimate goal of RA department in big pharmas is to make sure that their
products get to the market and stay in good shape in the market.
That is why RA is involved throughout the whole product life cycle.
From the very begining, RA is to make sure that all the manufacturing
process follow certain standard, either ISO standard for international/EU standard, or
21CFR 210 cGMP standard for drugs.
Then the product line moves to pre-clinical then, cGLP is the rule.
Afte... 阅读全帖
T****8
发帖数: 505
9
来自主题: Pharmaceutical版 - 老生常谈的话题:regulatory affairs
Well,we are talking about getting started in RA and not a seasoned senior
here. This is not about planning IND strategy for efficient BLA approval, it
's about getting into RA field. Folks can get started in learning the basics
, such as preparing submission forms, learning preparing eCTD, global
submit, so start helping out these little things that will get you in the
door.
On the other hand, people can also think about getting into the facility
auditor job, which should pay even better than RA... 阅读全帖
N****n
发帖数: 1208
10
Job Title
Director, Biostatistics
Region
Asia Pacific
Key Roles
• The Director contributes to and leads strategic initiatives for
the structure and development of the Biostatistics department in order to
achieve the overall goals and mission of company.
• The Director is responsible for managing a team of Statisticians
or Managers who themselves manage teams of statisticians involved in the
production of clinical trial reports and in the provision of statistical
services.
Main ... 阅读全帖
h***x
发帖数: 586
11
CALIFORNIA:
0000087272
SAS Programmer (12m)
Bachelor's or Masters in Computer Science or other relevant (Engineering)
degrees with 5+ years of pharmaceutical experience preferred- The work
experience should include at least two years of technical leadership in a
statistical programming environment in a pharmaceutical or biotechnology
environment including the analysis and reporting of clinical trial data-
Knowledge and application of p-values, confidence intervals, linear
regression analysis, ad... 阅读全帖
s**********8
发帖数: 25265
J*****2
发帖数: 253
13
来自主题: RegulatoryAffairs版 - Tips for preparing a successful eCTD
谢谢你在此版的辛勤耕耘!
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