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RegisterGeneral remarks [RSABE / ABEL]
Hi to Danmark, wish I was there 
Yeah, sound scientific discussion, that would be it, regarding regulatory requirements. And that's why this consultation process was invented for EMA guidelines, I guess (politics is not my business, you can imagine
).
But did it work out well yet? We had the discussion on the scientific basis of Ctrough in the MR guideline recently.
And I think there was at least one large-scale workshop/conference on this guideline, but apparently not everything was on the table (at that time?) or discussed to the very end.
In my opinion the structure of a guideline should clearly state the problems the current draft is going to address, sound scientific analysis of this problem and conclusions to be drawn based on this. That's what EMA or any other agency expect you to present at an Sci. Adv. meeting, so why not doing it the same way when formulating new regulatory requirements?
I think what we see currently is not state-of-the-art scientific discussion of the real problems. Why does not EMA together with external experts set up an online discussion board for new draft guidelines instead of a deadline for comments (which end nowhere?)? Everybody could participate and in the end there might be a more rational (but at least a much more transparent) evaluation of drafts.
Let's have open source guidelines the sourceforge.org-style. We are in 2015...
PS: I love lively discussions, as you can imagine
Yeah, sound scientific discussion, that would be it, regarding regulatory requirements. And that's why this consultation process was invented for EMA guidelines, I guess (politics is not my business, you can imagine
). But did it work out well yet? We had the discussion on the scientific basis of Ctrough in the MR guideline recently.
And I think there was at least one large-scale workshop/conference on this guideline, but apparently not everything was on the table (at that time?) or discussed to the very end.
In my opinion the structure of a guideline should clearly state the problems the current draft is going to address, sound scientific analysis of this problem and conclusions to be drawn based on this. That's what EMA or any other agency expect you to present at an Sci. Adv. meeting, so why not doing it the same way when formulating new regulatory requirements?
I think what we see currently is not state-of-the-art scientific discussion of the real problems. Why does not EMA together with external experts set up an online discussion board for new draft guidelines instead of a deadline for comments (which end nowhere?)? Everybody could participate and in the end there might be a more rational (but at least a much more transparent) evaluation of drafts.
Let's have open source guidelines the sourceforge.org-style. We are in 2015...
PS: I love lively discussions, as you can imagine
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- EMA oracle Helmut 2015-01-27 16:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
- EMA oracle nobody 2015-01-28 09:04
- EMA oracle ElMaestro 2015-01-28 13:11
- EMA oracle nobody 2015-01-28 09:04
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
- Response from Alfredo García-Arieta nobody 2015-01-30 14:55
- Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
- Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
- Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
- General remarks ElMaestro 2015-02-01 18:43
- General remarksnobody 2015-02-01 22:04
- General remarks Helmut 2015-02-02 00:48
- General remarks nobody 2015-02-02 08:09
- General remarks Helmut 2015-02-02 14:06
- TIE: questions mittyri 2015-02-03 12:44
- TIE: questions Helmut 2015-02-03 13:24
- TIE: questions mittyri 2015-02-03 12:44
- General remarks Helmut 2015-02-02 14:06
- FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
- FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
- FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
- FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
- FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
- General remarks nobody 2015-02-02 08:09
- Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
- Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
- Response from Alfredo García-Arieta nobody 2015-01-30 14:55
- New Zealand nobody 2015-01-31 11:25
- New Zealand Helmut 2015-02-01 16:08
- New Zealand nobody 2015-02-01 22:08
- New Zealand Helmut 2015-02-01 23:54
- New Zealand nobody 2015-02-02 08:07
- New Zealand Helmut 2015-02-01 23:54
- New Zealand nobody 2015-02-01 22:08
- New Zealand Helmut 2015-02-01 16:08
Ing. Helmut Schütz