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第
篇
序号
主题
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作者
最后回复
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● 如何全面提高医药法规注册人员的综合素质
(2.6k)
--
fafaliu
2014-10-22
--
2
● 新版发开班包子
(9b)
22/350
skycaptain08
2014-09-19
betep
12-03 16:06
3
● 求书 Fundamentals of US Regulatory Affairs,哪个
(127b)
0/78
Spartaner
2018-08-08
--
4
● 今年秋天有没有人考RAC?
(38b)
8/704
fstella
2016-08-02
xiaoshang200
08-01 22:35
5
● 本班微信群建立了吗?
(51b)
0/61
lala82
2018-06-20
--
6
● 2018 FALL - RAC exam prep
(13b)
0/129
AP020521
2018-03-23
--
7
● 你会原谅海底捞吗?
(2.5k)
0/157
hiphop
2017-09-19
--
8
● 醉酒一次等于得次肝炎!8招把喝酒伤害降到最低
(4.0k)
0/231
redrivers
2017-08-13
--
9
m
● 大家都是做什么方向的?
(127b)
32/2113
NCMT
2014-10-09
emcare
07-09 13:49
10
● CFDA Issues New Drug/Clinical Trial Approval Regu
(5.5k)
2/444
huiqiang80
2015-11-22
ceelowswift
07-04 01:05
11
● 寻找志同道合的朋友 求书和practice exam
(43b)
0/151
GoldenYJX
2017-07-03
--
12
● FDA医疗器械注册 (转载)
(248b)
1/463
OE
2017-01-08
spider2009
06-24 23:36
13
● FDA Consultant NEEDED
(88b)
3/560
halcyonblue
2016-05-19
spider2009
06-24 23:34
14
@
● 【会议+Networking+华人联谊】4月1日马里兰SAPA-DC
(2.5k)
0/179
sapadc
2017-03-14
--
15
● baodao
(2b)
1/234
MichaelGove
2016-10-31
skycaptain08
01-23 17:13
16
● 求 Regulatory affairs entry-level 工作
(173b)
1/632
xyray
2016-10-02
skycaptain08
01-23 17:13
17
● 搞个临床CRO公司怎么样 (转载)
(320b)
3/744
huiqiang80
2016-07-08
SmallGTPase
01-02 01:26
18
● Postdoc转RA,几种方案求建议
(1.1k)
3/883
sixwalnut
2016-04-14
slootskaya
12-08 11:14
19
● 如何查 ANDA 需要做临床study ???
(61b)
0/166
xyray
2016-10-08
--
20
@
● 【大会】9月17日首都华盛顿“药政改革与可持续发展”
(1.6k)
0/152
xiaozuanfeng
2016-09-11
--
21
● 请问一个专业软件 (转载)
(361b)
0/195
forrestdone
2016-07-26
--
22
● 谁知道请CRO帮忙写个IND或者510k大概多少钱
(9b)
0/356
baoozi
2016-06-10
--
23
● 求 IEC 60812 (FMEA)
(158b)
3/187
zhaohd
2016-03-30
skycaptain08
04-29 18:30
24
● 求购Fundamentals of US Regulatory Affairs, Ninth
(30b)
0/399
concona
2016-03-12
--
25
● BS EN 50581:2012
(85b)
0/178
zhaohd
2016-03-02
--
26
● Johnson & Johnson to Pay $72M for Talcum Powd
(351b)
0/229
icool
2016-02-25
--
27
m
● 如何全面提高医药法规注册人员的综合素质
(2.6k)
14/1276
fafaliu
2014-10-22
--
28
● 2016 春季 RAC 考试学习小组
(34b)
1/416
zhengyy91
2015-12-28
wuwulala
02-09 16:22
29
● 请问RAC考试 training , 标题要长长长长。。。。谢
(366b)
0/405
roybean
2016-01-15
--
30
● 真心请教--是否值得读regulatory affairs 的 online
(812b)
5/1155
roybean
2015-05-27
iminusc
01-12 21:51
31
● 问一个中国药品在美国注册的问题
(164b)
4/434
iminusc
2015-09-22
iminusc
01-12 21:39
32
● Small Business and Industry Education Series
(179b)
0/159
skycaptain08
2016-01-04
--
33
● 借贵宝地问一下,什么样的荧光酶可用于测试农产品的
(57b)
0/113
hartshornedr
2015-10-29
--
34
● 2015 春季RAC考试学习小组
(39b)
6/809
zzjoe
2014-12-22
gylwjq
10-29 02:36
35
● 新人入行求建议
(245b)
1/685
bigbee
2015-09-17
cccooo
09-23 22:44
36
● RAC经验咨询
(141b)
1/614
wuwulala
2015-09-20
nkaspirin
09-21 23:54
37
● 太阳神膏药可以在美国卖吗
(362b)
3/315
mitbbs012
2015-09-10
mitbbs012
09-15 02:10
38
● 求书 Fundamentals of us regulatory affairs, eight
(39b)
5/663
dingfan
2015-04-07
huiqiang80
07-15 02:59
39
m
● 分享个FDA 101的课程吧,另外打算考2015 fall的RAC
(301b)
0/758
hellozero
2015-07-05
--
40
● 下半年的RAC考试
(75b)
4/593
arkane
2015-06-15
arkane
06-18 00:29
41
● 大家是如何做到regulatory affairs 的?
(26b)
7/1695
amstel
2014-10-13
skycaptain08
06-09 02:52
42
● 2015春季考试时间确认?
(134b)
2/364
DClife
2015-01-16
Nefertiti
05-28 22:44
43
● canada and EU GMP
(162b)
0/227
skycaptain08
2015-05-27
--
44
● Regulatory body TUV
(108b)
7/381
arkane
2015-03-20
liujiening
05-12 21:22
45
● 感谢开版的功勋们, 特此开贴邀春季考考完的大师们分
(58b)
0/226
michellejia
2015-04-28
--
46
● RA工作身份问题
(100b)
1/482
qwqwer
2015-04-12
dingfan
04-14 15:04
47
● 有RAC无工作经验怎样进入这一行呢
(419b)
2/1007
twinfishgirl
2014-12-10
dingfan
04-06 15:08
48
● CDRH Industry Basics Workshop (All Day Webinar)
(109b)
1/289
skycaptain08
2015-02-16
dingfan
04-06 15:02
49
● RAC考试报名问题,急
(362b)
1/458
happyaby
2015-04-03
happyaby
04-03 02:17
50
● US regulaotry affairs overview
(60b)
3/760
skycaptain08
2014-11-10
fruitpiggie
03-23 23:36
51
● 怎么找手机医用app申请510K的例子?
(111b)
4/311
bbs1105
2015-01-10
fafaliu
02-11 14:54
52
● 想转到Regular Affair,不知道这个行业对语言要求高
(76b)
7/1178
what4
2014-11-05
fafaliu
02-11 12:29
53
● DMF - drug master file
(320b)
0/279
skycaptain08
2015-01-27
--
54
● 求分享最新版 fundamentals of regulatory affairs
(95b)
1/505
lancy8
2015-01-24
skycaptain08
01-27 01:38
55
● happy new year
(6b)
2/181
skycaptain08
2015-01-09
Twentybucks
01-14 14:01
56
● 为什么要做RAC
(175b)
2/870
layerstrong
2015-01-09
skycaptain08
01-12 08:16
57
● RAC 考试需要什么资料呢?
(8b)
2/673
cindy2016
2015-01-05
cindy2016
01-10 23:57
58
● 送一份RAC US mock exam
(19b)
2/580
skycaptain08
2014-11-11
christinagu
01-07 17:08
59
● 请教板上各位大牛
(267b)
6/430
arch1024
2014-11-14
Jie2012
01-05 10:53
60
● Tips for preparing a successful eCTD
(75b)
2/344
skycaptain08
2014-11-19
Jie2012
01-05 10:51
61
● 求 加入rac学习小组
(46b)
1/349
lancy8
2014-12-24
Jie2012
01-05 10:50
62
● PQRI workshop : quality, product development and
(84b)
1/275
skycaptain08
2014-11-05
cindy2016
01-02 19:27
63
● risk management
(113b)
2/365
skycaptain08
2014-11-21
kuaicanmian
12-05 00:34
64
● FDA's Latest Biosimilars Guidance: How to Show Bi
(244b)
0/290
skycaptain08
2014-12-04
--
65
● New Drug Development and Review Process
(90b)
2/337
skycaptain08
2014-12-02
telanx
12-02 23:09
66
● Design Control Guidance For Medical Device Manufa
(94b)
0/206
skycaptain08
2014-12-02
--
67
● Clinical Trial Design Principles for Dummies
(535b)
0/353
skycaptain08
2014-11-25
--
68
● Meetings with FDA
(126b)
0/309
skycaptain08
2014-11-21
--
69
● EU RAC mock exam
(146b)
1/283
Twentybucks
2014-11-21
skycaptain08
11-21 16:51
70
● Stability testing of APIs and finished products
(175b)
5/245
skycaptain08
2014-11-13
skycaptain08
11-19 21:50
71
● 问关于RAC考试
(72b)
4/712
what4
2014-11-11
Jie2012
11-18 08:35
72
● one comment
(102b)
2/253
skycaptain08
2014-11-13
skycaptain08
11-16 21:51
73
● 物理背景没有医学相关知识的能进入这行当吗
(256b)
2/566
dragon2012
2014-10-26
abovewater7
11-15 17:00
74
● prepare an FDA pre-approval inspection (PAI)
(59b)
6/336
skycaptain08
2014-11-11
skycaptain08
11-14 17:40
75
● Use of International Standard ISO- 10993 - FDA's
(104b)
0/156
skycaptain08
2014-11-13
--
76
● pharmacovigilance scientist
(106b)
1/341
nicety
2014-11-13
skycaptain08
11-13 13:10
77
● 受到presentation的
(31b)
4/264
skycaptain08
2014-11-06
skycaptain08
11-07 20:22
78
● 版三,
(10b)
5/222
skycaptain08
2014-10-09
gspsy
11-06 09:45
79
● some helpful presentation for pharm, device, qual
(67b)
0/186
skycaptain08
2014-11-05
--
80
● Unique Device Identification - UDI
(124b)
0/140
skycaptain08
2014-11-04
--
81
● special assessment protocol
(1.2k)
0/213
skycaptain08
2014-10-29
--
82
● draft guidance - comparability protocol
(99b)
1/181
skycaptain08
2014-10-29
skycaptain08
10-29 02:40
83
● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。
(126b)
19/349
skycaptain08
2014-09-19
Twentybucks
10-27 11:29
84
● regulatory 工作机会 10/1/2014 to 12/31/2014
(40b)
3/944
skycaptain08
2014-10-19
jhs
10-20 19:27
85
● 关于工作机会贴
(57b)
0/354
skycaptain08
2014-10-19
--
86
● 是不是大家做cmc的多?
(23b)
3/491
ORC
2014-10-03
lalalahehe
10-18 21:42
87
● 505(b)(2) draft guidance
(59b)
0/189
skycaptain08
2014-10-17
--
88
● 恭喜版二上任.
(12b)
5/223
skycaptain08
2014-10-09
aapplemei
10-17 13:30
89
● FDA Announces Major Agency Reorganization, With F
(194b)
0/199
skycaptain08
2014-10-16
--
90
● Pediatric Study Plans
(118b)
0/205
skycaptain08
2014-10-15
--
91
● Re: 请教一个制药过程中金属分析的问题 (转载)
(1.2k)
0/191
skycaptain08
2014-10-14
--
92
● CMC Considerations for a successful regulatory su
(107b)
0/275
skycaptain08
2014-10-14
--
93
● 准备考秋天的RAC US
(79b)
1/398
niu88
2014-10-13
Olymzoro
10-13 21:29
94
m
● 版叔promise大家的材料~
(258b)
1/394
Twentybucks
2014-10-13
skycaptain08
10-13 17:28
95
● FDA Announces Major Regulatory Changes, With Spec
(5.9k)
0/270
skycaptain08
2014-10-09
--
96
● 海归可以做regulatory affair吗?在美国的学位和经验
(172b)
3/815
lianqiao
2014-10-03
nkaspirin
10-03 14:26
97
● some presentation on pharmaceutical quality relat
(40b)
0/234
skycaptain08
2014-09-29
--
98
● ICH Q8, 9 10 training.
(97b)
0/303
skycaptain08
2014-09-27
--
99
● FDA eCTD Table of Contents Headings and Hierarchy
(126b)
0/226
skycaptain08
2014-09-27
--
100
● FDA meeting
(59b)
0/259
skycaptain08
2014-09-26
--
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健康产品法规科学版
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