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序号   主题 跟贴/点击 作者 最后回复
提示 提示 ● 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
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2   ● FDA Consultant NEEDED (88b) 2/292halcyonblue
2016-05-19
ngong
05-22 18:06
3   ● QA ,Validation, RA 之间转工作容易吗? (189b) 1/38leuning
2017-04-15
leuning
04-28 00:04
4  @ ● 【会议+Networking+华人联谊】4月1日马里兰SAPA-DC (2.5k) 0/66sapadc
2017-03-14
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5   ● baodao (2b) 1/124MichaelGove
2016-10-31
skycaptain08
01-23 17:13
6   ● 求 Regulatory affairs entry-level 工作 (173b) 1/240xyray
2016-10-02
skycaptain08
01-23 17:13
7   ● FDA医疗器械注册 (转载) (248b) 0/174OE
2017-01-08
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8   ● 搞个临床CRO公司怎么样 (转载) (320b) 3/532huiqiang80
2016-07-08
SmallGTPase
01-02 01:26
9   ● Postdoc转RA,几种方案求建议 (1.1k) 3/601sixwalnut
2016-04-14
slootskaya
12-08 11:14
10   ● 今年秋天有没有人考RAC? (38b) 3/243fstella
2016-08-02
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11   ● 如何查 ANDA 需要做临床study ??? (61b) 0/92xyray
2016-10-08
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12  @ ● 【大会】9月17日首都华盛顿“药政改革与可持续发展” (1.6k) 0/74xiaozuanfeng
2016-09-11
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13   ● 请问一个专业软件 (转载) (361b) 0/107forrestdone
2016-07-26
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14   ● 谁知道请CRO帮忙写个IND或者510k大概多少钱 (9b) 0/176baoozi
2016-06-10
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15   ● 求 IEC 60812 (FMEA) (158b) 3/96zhaohd
2016-03-30
skycaptain08
04-29 18:30
16   ● CFDA Issues New Drug/Clinical Trial Approval Regu (5.5k) 1/236huiqiang80
2015-11-22
zhaohd
03-31 02:44
17   ● 求购Fundamentals of US Regulatory Affairs, Ninth (30b) 0/204concona
2016-03-12
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18   ● BS EN 50581:2012 (85b) 0/88zhaohd
2016-03-02
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19   ● Johnson & Johnson to Pay $72M for Talcum Powd (351b) 0/134icool
2016-02-25
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20 m ● 如何全面提高医药法规注册人员的综合素质 (2.6k) 14/929fafaliu
2014-10-22
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21   ● 2016 春季 RAC 考试学习小组 (34b) 1/269zhengyy91
2015-12-28
wuwulala
02-09 16:22
22   ● 请问RAC考试 training , 标题要长长长长。。。。谢 (366b) 0/229roybean
2016-01-15
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23   ● 真心请教--是否值得读regulatory affairs 的 online (812b) 5/913roybean
2015-05-27
iminusc
01-12 21:51
24   ● 问一个中国药品在美国注册的问题 (164b) 4/303iminusc
2015-09-22
iminusc
01-12 21:39
25   ● Small Business and Industry Education Series (179b) 0/110skycaptain08
2016-01-04
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26   ● 借贵宝地问一下,什么样的荧光酶可用于测试农产品的 (57b) 0/75hartshornedr
2015-10-29
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27   ● 2015 春季RAC考试学习小组 (39b) 6/619zzjoe
2014-12-22
gylwjq
10-29 02:36
28   ● 新人入行求建议 (245b) 1/522bigbee
2015-09-17
cccooo
09-23 22:44
29   ● RAC经验咨询 (141b) 1/440wuwulala
2015-09-20
nkaspirin
09-21 23:54
30   ● 太阳神膏药可以在美国卖吗 (362b) 3/229mitbbs012
2015-09-10
mitbbs012
09-15 02:10
31   ● 求书 Fundamentals of us regulatory affairs, eight (39b) 5/499dingfan
2015-04-07
huiqiang80
07-15 02:59
32 m ● 分享个FDA 101的课程吧,另外打算考2015 fall的RAC (301b) 0/586hellozero
2015-07-05
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33   ● 下半年的RAC考试 (75b) 4/404arkane
2015-06-15
arkane
06-18 00:29
34   ● 大家是如何做到regulatory affairs 的? (26b) 7/1265amstel
2014-10-13
skycaptain08
06-09 02:52
35   ● 2015春季考试时间确认? (134b) 2/245DClife
2015-01-16
Nefertiti
05-28 22:44
36   ● canada and EU GMP (162b) 0/148skycaptain08
2015-05-27
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37 m ● 大家都是做什么方向的? (127b) 31/1645NCMT
2014-10-09
liujiening
05-12 21:27
38   ● Regulatory body TUV (108b) 7/279arkane
2015-03-20
liujiening
05-12 21:22
39   ● 感谢开版的功勋们, 特此开贴邀春季考考完的大师们分 (58b) 0/161michellejia
2015-04-28
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40   ● RA工作身份问题 (100b) 1/388qwqwer
2015-04-12
dingfan
04-14 15:04
41   ● 有RAC无工作经验怎样进入这一行呢 (419b) 2/829twinfishgirl
2014-12-10
dingfan
04-06 15:08
42   ● CDRH Industry Basics Workshop (All Day Webinar) (109b) 1/221skycaptain08
2015-02-16
dingfan
04-06 15:02
43   ● RAC考试报名问题,急 (362b) 1/263happyaby
2015-04-03
happyaby
04-03 02:17
44   ● US regulaotry affairs overview (60b) 3/598skycaptain08
2014-11-10
fruitpiggie
03-23 23:36
45   ● 怎么找手机医用app申请510K的例子? (111b) 4/229bbs1105
2015-01-10
fafaliu
02-11 14:54
46   ● 想转到Regular Affair,不知道这个行业对语言要求高 (76b) 7/988what4
2014-11-05
fafaliu
02-11 12:29
47   ● DMF - drug master file (320b) 0/228skycaptain08
2015-01-27
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48   ● 求分享最新版 fundamentals of regulatory affairs (95b) 1/344lancy8
2015-01-24
skycaptain08
01-27 01:38
49   ● happy new year (6b) 2/114skycaptain08
2015-01-09
Twentybucks
01-14 14:01
50   ● 为什么要做RAC (175b) 2/642layerstrong
2015-01-09
skycaptain08
01-12 08:16
51   ● RAC 考试需要什么资料呢? (8b) 2/453cindy2016
2015-01-05
cindy2016
01-10 23:57
52   ● 送一份RAC US mock exam (19b) 2/418skycaptain08
2014-11-11
christinagu
01-07 17:08
53   ● 请教板上各位大牛 (267b) 6/284arch1024
2014-11-14
Jie2012
01-05 10:53
54   ● Tips for preparing a successful eCTD (75b) 2/205skycaptain08
2014-11-19
Jie2012
01-05 10:51
55   ● 求 加入rac学习小组 (46b) 1/210lancy8
2014-12-24
Jie2012
01-05 10:50
56   ● PQRI workshop : quality, product development and (84b) 1/167skycaptain08
2014-11-05
cindy2016
01-02 19:27
57   ● risk management (113b) 2/253skycaptain08
2014-11-21
kuaicanmian
12-05 00:34
58   ● FDA's Latest Biosimilars Guidance: How to Show Bi (244b) 0/196skycaptain08
2014-12-04
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59   ● New Drug Development and Review Process (90b) 2/217skycaptain08
2014-12-02
telanx
12-02 23:09
60   ● Design Control Guidance For Medical Device Manufa (94b) 0/131skycaptain08
2014-12-02
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61   ● Clinical Trial Design Principles for Dummies (535b) 0/233skycaptain08
2014-11-25
--
62   ● Meetings with FDA (126b) 0/254skycaptain08
2014-11-21
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63   ● EU RAC mock exam (146b) 1/174Twentybucks
2014-11-21
skycaptain08
11-21 16:51
64   ● Stability testing of APIs and finished products (175b) 5/175skycaptain08
2014-11-13
skycaptain08
11-19 21:50
65   ● 问关于RAC考试 (72b) 4/498what4
2014-11-11
Jie2012
11-18 08:35
66   ● one comment (102b) 2/176skycaptain08
2014-11-13
skycaptain08
11-16 21:51
67   ● 物理背景没有医学相关知识的能进入这行当吗 (256b) 2/435dragon2012
2014-10-26
abovewater7
11-15 17:00
68   ● prepare an FDA pre-approval inspection (PAI) (59b) 6/228skycaptain08
2014-11-11
skycaptain08
11-14 17:40
69   ● Use of International Standard ISO- 10993 - FDA's (104b) 0/100skycaptain08
2014-11-13
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70   ● pharmacovigilance scientist (106b) 1/201nicety
2014-11-13
skycaptain08
11-13 13:10
71   ● 受到presentation的 (31b) 4/204skycaptain08
2014-11-06
skycaptain08
11-07 20:22
72   ● 版三, (10b) 5/173skycaptain08
2014-10-09
gspsy
11-06 09:45
73   ● some helpful presentation for pharm, device, qual (67b) 0/144skycaptain08
2014-11-05
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74   ● Unique Device Identification - UDI (124b) 0/95skycaptain08
2014-11-04
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75   ● special assessment protocol (1.2k) 0/118skycaptain08
2014-10-29
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76   ● draft guidance - comparability protocol (99b) 1/107skycaptain08
2014-10-29
skycaptain08
10-29 02:40
77   ● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。 (126b) 19/270skycaptain08
2014-09-19
Twentybucks
10-27 11:29
78   ● regulatory 工作机会 10/1/2014 to 12/31/2014 (40b) 3/800skycaptain08
2014-10-19
jhs
10-20 19:27
79   ● 关于工作机会贴 (57b) 0/258skycaptain08
2014-10-19
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80   ● 是不是大家做cmc的多? (23b) 3/357ORC
2014-10-03
lalalahehe
10-18 21:42
81   ● 505(b)(2) draft guidance (59b) 0/125skycaptain08
2014-10-17
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82   ● 恭喜版二上任. (12b) 5/130skycaptain08
2014-10-09
aapplemei
10-17 13:30
83   ● FDA Announces Major Agency Reorganization, With F (194b) 0/144skycaptain08
2014-10-16
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84   ● Pediatric Study Plans (118b) 0/127skycaptain08
2014-10-15
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85   ● Re: 请教一个制药过程中金属分析的问题 (转载) (1.2k) 0/134skycaptain08
2014-10-14
--
86   ● CMC Considerations for a successful regulatory su (107b) 0/161skycaptain08
2014-10-14
--
87   ● 准备考秋天的RAC US (79b) 1/295niu88
2014-10-13
Olymzoro
10-13 21:29
88 m ● 版叔promise大家的材料~ (258b) 1/282Twentybucks
2014-10-13
skycaptain08
10-13 17:28
89   ● FDA Announces Major Regulatory Changes, With Spec (5.9k) 0/177skycaptain08
2014-10-09
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90   ● 新版发开班包子 (9b) 20/226skycaptain08
2014-09-19
hellozero
10-06 11:06
91   ● 海归可以做regulatory affair吗?在美国的学位和经验 (172b) 3/628lianqiao
2014-10-03
nkaspirin
10-03 14:26
92   ● some presentation on pharmaceutical quality relat (40b) 0/148skycaptain08
2014-09-29
--
93   ● ICH Q8, 9 10 training. (97b) 0/186skycaptain08
2014-09-27
--
94   ● FDA eCTD Table of Contents Headings and Hierarchy (126b) 0/149skycaptain08
2014-09-27
--
95   ● FDA meeting (59b) 0/191skycaptain08
2014-09-26
--
96   ● 21CFR 820 QSR (257b) 0/125skycaptain08
2014-09-26
--
97   ● FDA guidance for industry (245b) 2/277skycaptain08
2014-09-23
skycaptain08
09-25 02:27
98   ● IRB - Institutional review board (125b) 1/209skycaptain08
2014-09-23
zorrozn
09-23 21:19
99   ● 招聘一名版二 (80b) 0/126skycaptain08
2014-09-22
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100   ● 恭喜开班 (53b) 4/114guan2006
2014-09-18
skycaptain08
09-22 18:28
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