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reg_info

  1. EMA: Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting scientifi... e-ra.eu/LO1Tb0 9:18 AM May 15th via twitterfeed
  2. EMA: Regulatory and procedural guideline: Appendix IV - Terms for batch number & expiry date to be used on oute... e-ra.eu/LWFR8x 4:55 AM May 10th via twitterfeed
  3. EMA: Regulatory and procedural guideline: Reflection paper for laboratories that perform the analysis or evalua... e-ra.eu/LDQEV5 5:14 AM May 8th via twitterfeed
  4. EMA: Scientific guideline: Guideline on quality, non-clinical and clinical aspects of medicinal products contai... e-ra.eu/J5OZFR 1:23 AM May 4th via twitterfeed
  5. CTFG: Questions and Answers to the Annual Safety Report. Frequently asked questions regarding the Development Safety Update Report (DSUR)... 6:47 AM May 1st via HootSuite
  6. CTFG: Questions and Answers by the CTFG on clinical trials. Answers to frequently asked questions e-ra.eu/JDiHjS 6:45 AM May 1st via bitly
  7. EMA: Regulatory and procedural guideline: Reflection paper on classification of advanced-therapy medicinal prod... e-ra.eu/JsQcVT 10:52 AM Apr 30th via twitterfeed
  8. EU: Member state agreement upon conditions under which the RMS can start MRP/DCP e-ra.eu/ICpB9S 6:11 AM Apr 30th via bitly
  9. EMA: Regulatory and procedural guideline: Member State contact points for translation review e-ra.eu/Kd5Tz5 5:33 AM Apr 26th via twitterfeed
  10. RT @ema_news: Companies can now submit applications for human medicines via eSubmission Gateway bit.ly/HZOQQg 7:25 AM Apr 25th via HootSuite
  11. EMA: Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for us... e-ra.eu/JchfTo 5:17 AM Apr 18th via twitterfeed
  12. EMA: Scientific guideline: Draft reflection paper on clinical aspects related to tissue engineered products, dr... e-ra.eu/ISIcRz 4:06 AM Apr 17th via twitterfeed
  13. EMA: Regulatory and procedural guideline: ICH guideline E2C (R2): Periodic benefit-risk evaluation report (PBRE... e-ra.eu/IR0jW3 10:02 AM Apr 16th via twitterfeed
  14. EMA: Regulatory and procedural guideline: Reflection paper on ethical and good-clinical-practice aspects of cli... e-ra.eu/IZl3vT 9:32 AM Apr 16th via twitterfeed
  15. EMA: Regulatory and procedural guideline: Initial notices for parallel distribution – March 2012 e-ra.eu/IOp0o3 7:58 AM Apr 16th via twitterfeed
  16. EMA: Scientific guideline: Questions and answers on post approval change management protocols e-ra.eu/J5JkLr 6:09 AM Apr 13th via twitterfeed
  17. EMA: Scientific guideline: Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), adopted e-ra.eu/J4ZDZ8 4:03 AM Apr 13th via twitterfeed
  18. EMA: Scientific guideline: Draft guideline on process validation, draft: consultation open e-ra.eu/ICH1Dw 4:03 AM Apr 13th via twitterfeed
  19. EMA: CHMP chair resigns, plus new conflict-of-interest rules e-ra.eu/IdKiH4 1:43 AM Apr 10th via bitly
  20. EMA: Regulatory and procedural guideline: Qualification opinion of Alzheimer’s disease novel methodologies/biom... e-ra.eu/I1t550 9:20 AM Apr 4th via twitterfeed
  • Name reg-info.com
  • Location Europe
  • Web http://reg-info.com/
  • Bio Regulatory intelligence sources for pharmaceutical professionals and others interested in the development of medicines compiled by Tim Felgate
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