Bioequivalence and Bioavailability Forum • ANVISA

ANVISA [Bioanalytics]

posted by Ohlbe – France, 2010-11-18 14:58 (5701 d 12:34 ago) – Posting: # 6165
Views: 12,216

Dear Marko,

❝ Working late? ;-)

I was in the US, it was not that late there...

❝ ANVISA...

Gosh... they really are special !
There was a session on global harmonisation of bioanalytical guidelines and expectations at the PSWC2010 (FIP/AAPS annual congress) in New Orleans on Monday. Eric Woolf from Merck gave a presentation with industry's position. His presentation was not really on US vs. EMA (current hot topic with the draft EMA guideline and FDA revising its own guidance) but rather on problems with other countries. He did not name any but it was quite obvious from the examples he gave that he was pointing at Brazil...

By the way, if I understood correctly the presentation from Ariadna Barra (ANVISA) at the same session, ANVISA will also update their bioanalytical guidance and some aspects will get closer to US/EMA.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

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    - ANVISAOhlbe 2010-11-18 13:58