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Registersolution vs IR in the EU [Design Issues]
Dear Helmut.
Thanks again.
your answers are clarifying the fact that in the absence of "common" base for comparison between reference to developed product: clinical data will be required in order to assure the similarity.
As for
Israel's guidlines if complete adoption of EU directive,
nevertheless minor changes sometimes are adopted in a specific case
I presented today the forum and our subject of "solution vs IR in the EU" to my managment and everyone were highly impressed by the professional support in this forum.
Very well done! helmut and everyone here.
Best regards,
Tali
Thanks again.
your answers are clarifying the fact that in the absence of "common" base for comparison between reference to developed product: clinical data will be required in order to assure the similarity.
As for
❝ Unfortunatelly I have no experience with Israel's guidelines and can only
❝ refer to European practices.
Israel's guidlines if complete adoption of EU directive,
nevertheless minor changes sometimes are adopted in a specific case
I presented today the forum and our subject of "solution vs IR in the EU" to my managment and everyone were highly impressed by the professional support in this forum.
Very well done! helmut and everyone here.
Best regards,
Tali
Complete thread:
- tablets versus solution in BE talr 2008-10-14 17:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- tablets versus solution in BE Helmut 2008-10-14 19:55
- tablets versus solution in BE talr 2008-10-14 21:23
- solution vs IR in the EU Helmut 2008-10-15 13:41
- solution vs IR in the EUtalr 2008-10-15 20:30
- Israeli Guideline Helmut 2008-10-15 22:14
- solution vs IR in the EUtalr 2008-10-15 20:30
- solution vs IR in the EU Helmut 2008-10-15 13:41
- tablets versus solution in BE talr 2008-10-14 21:23
- tablets versus solution in BE Helmut 2008-10-14 19:55
Ing. Helmut Schütz