Bioequivalence and Bioavailability Forum

EMA… [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2013-12-09 13:45 (4214 d 06:42 ago) – Posting: # 12025
Views: 25,163

Hi Kumar,

❝ […] EMA should also include the provision of submitting complete protocol for review and comment before study initiation in sequential design to avoid such situations.

Don’t be too optimistic. All the deficiency letters in my presentations came from studies which were performed in the EU. Hence, the protocols were approved by regulatory authorities where the CROs are located. In the “worst case MRP” you might have to face 31 different opinions (28 member states + Iceland, Liechtenstein, Norway).

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Only if you opt for the centralised procedure you could submit the protocol to EMA for approval.

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—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

Complete thread:

• Acceptance by FDA/CDER Mahesh 2013-08-06 06:12 
  • Two stage BE design ElMaestro 2013-08-06 10:05
  • Two stage BE design Helmut 2013-08-06 15:31
    • Two stage BE design Mahesh 2013-08-07 06:51
      • Two stage BE design kumarnaidu 2013-10-17 15:08
        • Two stage BE design ElMaestro 2013-10-17 17:28
          • Two stage BE design kumarnaidu 2013-10-18 05:59
            • EMA vs. rest of the world Helmut 2013-10-18 14:42
          • Two stage BE design — cold water thrown on our head Shuanghe 2013-10-18 10:05
            • Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
              • Change in statistical design kumarnaidu 2013-10-19 07:52
                • Bad idea Helmut 2013-10-19 15:04
                  • Bad idea kumarnaidu 2013-10-21 06:01
                    • Change to Method B? Helmut 2013-10-21 14:51
                      • Change to Method B? kumarnaidu 2013-10-22 06:15
                        • Simulations Helmut 2013-10-22 13:20
              • Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
                • Reach for the stars Helmut 2013-10-22 13:05
                  • Alpha inflation in two stage design kumarnaidu 2013-12-04 13:43
                    • Deficiency letters Helmut 2013-12-04 14:50
                      • Deficiency letters kumarnaidu 2013-12-05 06:18
                        • Simulations Helmut 2013-12-05 15:51
                          • Simulations kumarnaidu 2013-12-05 16:07
                            • Simulations Helmut 2013-12-05 16:55
                              • Simulations kumarnaidu 2013-12-06 06:07
                                • Ejaculatio praecox Helmut 2013-12-06 14:30
                                  • Ejaculatio praecox kumarnaidu 2013-12-06 15:13
                                    • All effects fixed Helmut 2013-12-06 15:31
                                      • All effects fixed kumarnaidu 2013-12-09 07:33
                                        • EMA…Helmut 2013-12-09 12:45