Bioequivalence and Bioavailability Forum • EMA: NSA-approach

EMA: NSA-approach [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2014-09-19 21:28 (4301 d 08:48 ago) – Posting: # 13548
Views: 5,002

Thanks again Helmut.

I hope EMA would apply a bit of change control if they force others to use it. The EMA homepage with guidelines has a column with "remarks". It wouldn't hurt if someone at EMA actually used that column to write e.g. "Hi mom!" or "Updated Sept 15. 2014, change enforced as of the same date." or something.
Otherwise applicants could later (once the entry slips off the rss feed) come into a situation where they cannot prove that they fulfilled the requirements at the time of submission and at the time of bioanalysis.

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Pass or fail!
ElMaestro

Complete thread:

EMA: GL on bioanalytical method validation Rev.1 Helmut 2014-09-19 17:09
- EMA: Guideline on bioanalytical method validation Rev.1 ElMaestro 2014-09-19 17:39
  - EMA: NSA-approach Helmut 2014-09-19 18:02
    - EMA: NSA-approachElMaestro 2014-09-19 19:28
      - EMA: NSA-approach nobody 2014-09-19 19:41
        
        EMA: NSA-approach ElMaestro 2014-09-20 21:41
        
        EMA: NSA-approach nobody 2014-09-21 16:59
- EMA: GL on bioanalytical method validation Rev.1 Ohlbe 2014-09-19 19:20
  - THX! Helmut 2014-09-22 16:34
  - EMA: GL on bioanalytical method validation Rev.1 Roberto 2014-09-23 17:52