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RegisterEMA: Method C “incompatible with CHMP GL” [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2013-10-09 16:50 (4645 d 23:06 ago) – Posting: # 11634
Views: 6,577
Hi RK,
I hope you mean EMA’s Methods A and B?
Method C is FDA’s – which is unlikely to be accepted according to the Q&A-document (only A and B are mentioned in the respective headings as “compatible with CHMP guideline”).
❝ I have compared the methods B and C,
I hope you mean EMA’s Methods A and B?
Method C is FDA’s – which is unlikely to be accepted according to the Q&A-document (only A and B are mentioned in the respective headings as “compatible with CHMP guideline”).
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Clarification on model statement in EMEA submission RK 2013-10-08 13:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: all effects fixed Helmut 2013-10-08 14:08
- EMA: all effects fixed RK 2013-10-09 06:32
- EMA: all effects fixed - Method A! d_labes 2013-10-09 08:30
- EMA: Method C “incompatible with CHMP GL”Helmut 2013-10-09 14:50
- EMA: Method C “incompatible with CHMP GL” RK 2013-10-10 06:01
- EMA: all effects fixed RK 2013-10-09 06:32
- EMA: all effects fixed Helmut 2013-10-08 14:08
Ing. Helmut Schütz