Great discussion [Design Issues]

posted by ElMaestro  – Belgium?, 2020-01-02 15:31 (300 d 13:35 ago) – Posting: # 21051
Views: 3,589

Hi all,

interesting discussions here.

» Question: Where should such a system be located? At the EMA?

Is a crossparticipation effort truly necessary across EU?

Some pros and cons as I see the issue and I am not talking legal affairs here:

Pros:
  1. If we require /enforce/inspect/question anything about it in region A (like India), then we should do so also in region B (like EU).
  2. EU would be forerunners. Someone in a penguin suit would have an opportunity to go on TV and brag about initiaties and patient concerns and sip champagne out of a tall glass, display friendly handshakes, canapes, live webinars with agency employees who read from a script and that kinda stuff. The opportunity to get good press is something that means a lot to the heads of agencies.
Cons:
  1. Is there a need? ICF is always in layman's national language. I did not hear much of crossparticipators across borders in EU, as far as I recall. It cannot be compared so well to India, where ICF's are usually in at least 3 languages (Hindi, English, and (the most common) state language(s)).
    But on the other hand, being proactive -if anyone wants to be so?- means you address an issue before the need arises. What if it turns out in 5 years there are current crossparticipators gaming the systems in Austria/Germany, or the Francolophystic countries? Do you wish to wait until you learn about them or do you want to do something to prevent it before it happens? After all, CAPA's are part of general GCP which regulators seem to like, right?
  2. Expand a little further on Pros pt 1. and you will need to discuss China. A diplomatic crisis waiting to happen.

By the way: I do not know of any other indicator -should I call it biomarker??- of crossparticipation than HB (or hematocrit, RBC count etc). Do you know of any?
Of course DNA traces present in plasma are direct markers of subject identity posing huge technical and practical difficulties and that in itself is a discussion for another thread.
Can you guys think of any other biomarker/indicator unrelated to blood loss or the regenerative process?

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,477 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 05:06 UTC (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5