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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医疗器械注册 (转载) (248b) 0/109OE
2017-01-08
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3   ● 搞个临床CRO公司怎么样 (转载) (320b) 3/482huiqiang80
2016-07-08
SmallGTPase
01-02 01:26
4   ● Postdoc转RA,几种方案求建议 (1.1k) 3/503sixwalnut
2016-04-14
slootskaya
12-08 11:14
5   ● 今年秋天有没有人考RAC? (38b) 3/162fstella
2016-08-02
katrina5201
11-30 12:15
6   ● baodao (2b) 0/48MichaelGove
2016-10-31
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7   ● 如何查 ANDA 需要做临床study ??? (61b) 0/58xyray
2016-10-08
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8   ● 求 Regulatory affairs entry-level 工作 (173b) 0/95xyray
2016-10-02
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9  @ ● 【大会】9月17日首都华盛顿“药政改革与可持续发展” (1.6k) 0/44xiaozuanfeng
2016-09-11
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10   ● FDA Consultant NEEDED (88b) 1/214halcyonblue
2016-05-19
OneRepublic
07-31 01:57
11   ● 请问一个专业软件 (转载) (361b) 0/85forrestdone
2016-07-26
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12   ● 谁知道请CRO帮忙写个IND或者510k大概多少钱 (9b) 0/131baoozi
2016-06-10
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13   ● 求 IEC 60812 (FMEA) (158b) 3/78zhaohd
2016-03-30
skycaptain08
04-29 18:30
14   ● CFDA Issues New Drug/Clinical Trial Approval Regu (5.5k) 1/211huiqiang80
2015-11-22
zhaohd
03-31 02:44
15   ● 求购Fundamentals of US Regulatory Affairs, Ninth (30b) 0/158concona
2016-03-12
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16   ● BS EN 50581:2012 (85b) 0/71zhaohd
2016-03-02
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17   ● Johnson & Johnson to Pay $72M for Talcum Powd (351b) 0/114icool
2016-02-25
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18 m ● 如何全面提高医药法规注册人员的综合素质 (2.6k) 14/852fafaliu
2014-10-22
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19   ● 2016年RAC证书资料 (135b) 0/312wuwulala
2016-02-10
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20   ● 2016 春季 RAC 考试学习小组 (34b) 1/236zhengyy91
2015-12-28
wuwulala
02-09 16:22
21   ● 请问RAC考试 training , 标题要长长长长。。。。谢 (366b) 0/195roybean
2016-01-15
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22   ● 真心请教--是否值得读regulatory affairs 的 online (812b) 5/836roybean
2015-05-27
iminusc
01-12 21:51
23   ● 问一个中国药品在美国注册的问题 (164b) 4/266iminusc
2015-09-22
iminusc
01-12 21:39
24   ● Small Business and Industry Education Series (179b) 0/90skycaptain08
2016-01-04
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25   ● 借贵宝地问一下,什么样的荧光酶可用于测试农产品的 (57b) 0/61hartshornedr
2015-10-29
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26   ● 2015 春季RAC考试学习小组 (39b) 6/582zzjoe
2014-12-22
gylwjq
10-29 02:36
27   ● 新人入行求建议 (245b) 1/472bigbee
2015-09-17
cccooo
09-23 22:44
28   ● RAC经验咨询 (141b) 1/387wuwulala
2015-09-20
nkaspirin
09-21 23:54
29   ● 太阳神膏药可以在美国卖吗 (362b) 3/208mitbbs012
2015-09-10
mitbbs012
09-15 02:10
30   ● 求书 Fundamentals of us regulatory affairs, eight (39b) 5/450dingfan
2015-04-07
huiqiang80
07-15 02:59
31 m ● 分享个FDA 101的课程吧,另外打算考2015 fall的RAC (301b) 0/531hellozero
2015-07-05
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32   ● 下半年的RAC考试 (75b) 4/369arkane
2015-06-15
arkane
06-18 00:29
33   ● 大家是如何做到regulatory affairs 的? (26b) 7/1181amstel
2014-10-13
skycaptain08
06-09 02:52
34   ● 2015春季考试时间确认? (134b) 2/228DClife
2015-01-16
Nefertiti
05-28 22:44
35   ● canada and EU GMP (162b) 0/135skycaptain08
2015-05-27
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36 m ● 大家都是做什么方向的? (127b) 31/1584NCMT
2014-10-09
liujiening
05-12 21:27
37   ● Regulatory body TUV (108b) 7/257arkane
2015-03-20
liujiening
05-12 21:22
38   ● 感谢开版的功勋们, 特此开贴邀春季考考完的大师们分 (58b) 0/145michellejia
2015-04-28
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39   ● RA工作身份问题 (100b) 1/358qwqwer
2015-04-12
dingfan
04-14 15:04
40   ● 有RAC无工作经验怎样进入这一行呢 (419b) 2/783twinfishgirl
2014-12-10
dingfan
04-06 15:08
41   ● CDRH Industry Basics Workshop (All Day Webinar) (109b) 1/211skycaptain08
2015-02-16
dingfan
04-06 15:02
42   ● RAC考试报名问题,急 (362b) 1/224happyaby
2015-04-03
happyaby
04-03 02:17
43   ● US regulaotry affairs overview (60b) 3/554skycaptain08
2014-11-10
fruitpiggie
03-23 23:36
44   ● 怎么找手机医用app申请510K的例子? (111b) 4/210bbs1105
2015-01-10
fafaliu
02-11 14:54
45   ● 想转到Regular Affair,不知道这个行业对语言要求高 (76b) 7/942what4
2014-11-05
fafaliu
02-11 12:29
46   ● DMF - drug master file (320b) 0/208skycaptain08
2015-01-27
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47   ● 求分享最新版 fundamentals of regulatory affairs (95b) 1/312lancy8
2015-01-24
skycaptain08
01-27 01:38
48   ● happy new year (6b) 2/102skycaptain08
2015-01-09
Twentybucks
01-14 14:01
49   ● 为什么要做RAC (175b) 2/599layerstrong
2015-01-09
skycaptain08
01-12 08:16
50   ● RAC 考试需要什么资料呢? (8b) 2/423cindy2016
2015-01-05
cindy2016
01-10 23:57
51   ● 送一份RAC US mock exam (19b) 2/382skycaptain08
2014-11-11
christinagu
01-07 17:08
52   ● 请教板上各位大牛 (267b) 6/264arch1024
2014-11-14
Jie2012
01-05 10:53
53   ● Tips for preparing a successful eCTD (75b) 2/186skycaptain08
2014-11-19
Jie2012
01-05 10:51
54   ● 求 加入rac学习小组 (46b) 1/191lancy8
2014-12-24
Jie2012
01-05 10:50
55   ● PQRI workshop : quality, product development and (84b) 1/155skycaptain08
2014-11-05
cindy2016
01-02 19:27
56   ● risk management (113b) 2/228skycaptain08
2014-11-21
kuaicanmian
12-05 00:34
57   ● FDA's Latest Biosimilars Guidance: How to Show Bi (244b) 0/173skycaptain08
2014-12-04
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58   ● New Drug Development and Review Process (90b) 2/199skycaptain08
2014-12-02
telanx
12-02 23:09
59   ● Design Control Guidance For Medical Device Manufa (94b) 0/117skycaptain08
2014-12-02
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60   ● Clinical Trial Design Principles for Dummies (535b) 0/213skycaptain08
2014-11-25
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61   ● Meetings with FDA (126b) 0/239skycaptain08
2014-11-21
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62   ● EU RAC mock exam (146b) 1/144Twentybucks
2014-11-21
skycaptain08
11-21 16:51
63   ● Stability testing of APIs and finished products (175b) 5/158skycaptain08
2014-11-13
skycaptain08
11-19 21:50
64   ● 问关于RAC考试 (72b) 4/466what4
2014-11-11
Jie2012
11-18 08:35
65   ● one comment (102b) 2/159skycaptain08
2014-11-13
skycaptain08
11-16 21:51
66   ● 物理背景没有医学相关知识的能进入这行当吗 (256b) 2/406dragon2012
2014-10-26
abovewater7
11-15 17:00
67   ● prepare an FDA pre-approval inspection (PAI) (59b) 6/208skycaptain08
2014-11-11
skycaptain08
11-14 17:40
68   ● Use of International Standard ISO- 10993 - FDA's (104b) 0/88skycaptain08
2014-11-13
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69   ● pharmacovigilance scientist (106b) 1/182nicety
2014-11-13
skycaptain08
11-13 13:10
70   ● 受到presentation的 (31b) 4/194skycaptain08
2014-11-06
skycaptain08
11-07 20:22
71   ● 版三, (10b) 5/158skycaptain08
2014-10-09
gspsy
11-06 09:45
72   ● some helpful presentation for pharm, device, qual (67b) 0/128skycaptain08
2014-11-05
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73   ● Unique Device Identification - UDI (124b) 0/83skycaptain08
2014-11-04
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74   ● special assessment protocol (1.2k) 0/105skycaptain08
2014-10-29
--
75   ● draft guidance - comparability protocol (99b) 1/93skycaptain08
2014-10-29
skycaptain08
10-29 02:40
76   ● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。 (126b) 19/260skycaptain08
2014-09-19
Twentybucks
10-27 11:29
77   ● regulatory 工作机会 10/1/2014 to 12/31/2014 (40b) 3/777skycaptain08
2014-10-19
jhs
10-20 19:27
78   ● 关于工作机会贴 (57b) 0/234skycaptain08
2014-10-19
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79   ● 是不是大家做cmc的多? (23b) 3/335ORC
2014-10-03
lalalahehe
10-18 21:42
80   ● 505(b)(2) draft guidance (59b) 0/112skycaptain08
2014-10-17
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81   ● 恭喜版二上任. (12b) 5/116skycaptain08
2014-10-09
aapplemei
10-17 13:30
82   ● FDA Announces Major Agency Reorganization, With F (194b) 0/132skycaptain08
2014-10-16
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83   ● Pediatric Study Plans (118b) 0/111skycaptain08
2014-10-15
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84   ● Re: 请教一个制药过程中金属分析的问题 (转载) (1.2k) 0/121skycaptain08
2014-10-14
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85   ● CMC Considerations for a successful regulatory su (107b) 0/149skycaptain08
2014-10-14
--
86   ● 准备考秋天的RAC US (79b) 1/281niu88
2014-10-13
Olymzoro
10-13 21:29
87 m ● 版叔promise大家的材料~ (258b) 1/259Twentybucks
2014-10-13
skycaptain08
10-13 17:28
88   ● FDA Announces Major Regulatory Changes, With Spec (5.9k) 0/161skycaptain08
2014-10-09
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89   ● 新版发开班包子 (9b) 20/206skycaptain08
2014-09-19
hellozero
10-06 11:06
90   ● 海归可以做regulatory affair吗?在美国的学位和经验 (172b) 3/590lianqiao
2014-10-03
nkaspirin
10-03 14:26
91   ● some presentation on pharmaceutical quality relat (40b) 0/136skycaptain08
2014-09-29
--
92   ● ICH Q8, 9 10 training. (97b) 0/172skycaptain08
2014-09-27
--
93   ● FDA eCTD Table of Contents Headings and Hierarchy (126b) 0/124skycaptain08
2014-09-27
--
94   ● FDA meeting (59b) 0/178skycaptain08
2014-09-26
--
95   ● 21CFR 820 QSR (257b) 0/114skycaptain08
2014-09-26
--
96   ● FDA guidance for industry (245b) 2/259skycaptain08
2014-09-23
skycaptain08
09-25 02:27
97   ● IRB - Institutional review board (125b) 1/190skycaptain08
2014-09-23
zorrozn
09-23 21:19
98   ● 招聘一名版二 (80b) 0/114skycaptain08
2014-09-22
--
99   ● 恭喜开班 (53b) 4/100guan2006
2014-09-18
skycaptain08
09-22 18:28
100   ● 太赞了 终于批下来了 (49b) 1/240AP020521
2014-09-21
zorrozn
09-22 10:11
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