Log in
Register|
BE ☆ 2008-11-18 14:14 (6432 d 05:03 ago) Posting: # 2716 Views: 3,549 |
|
|
Dear Forum Members, Does anyone know if there are plans at EMEA to come out with Individual product BE recommendations, like the ones we have for USFDA. Best Regards, BE |
|
Helmut ★★★   Vienna, Austria, 2008-11-18 14:26 (6432 d 04:52 ago) @ BE Posting: # 2717 Views: 2,717 |
|
|
Dear BE - that's not your real name  ❝ Does anyone know if there are plans at EMEA to come out with Individual ❝ product BE recommendations, like the ones we have for USFDA. If you are thinking about 'small molecules' definitely neither existing recommendations, nor any plans to come up with some. For biosimilars, yes. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
ElMaestro ★★★ Denmark, 2008-11-18 14:39 (6432 d 04:38 ago) @ Helmut Posting: # 2718 Views: 2,655 |
|
|
❝ (...) nor any plans to come up with some. Hi HS, are you absolutely sure  ?EM. |
|
Helmut ★★★ Vienna, Austria, 2008-11-18 15:00 (6432 d 04:17 ago) @ ElMaestro Posting: # 2719 Views: 2,775 |
|
|
Dear ElMaestro! ❝ are you absolutely sure OK, to be more precise:
 — 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 |
|
Ohlbe ★★★ France, 2008-11-18 23:02 (6431 d 20:15 ago) @ Helmut Posting: # 2724 Views: 2,711 |
|
|
Dear ElMaestro and Helmut, The message at the EGA meeting a few weeks ago was that we will end up with sort of product recommendations and interpretations of the future guideline through CHMP referrals  This will be too late for most users... But it seems they already have a hard time finding some kind of agreement on a general guideline. Regards Ohlbe |
Ing. Helmut Schütz