online BE course? [Conferences / Workshops]

posted by ElMaestro  – Denmark, 2016-08-26 22:25 (1973 d 23:22 ago) – Posting: # 16599
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Hi javier,

» This is my first post, (so please forget the mistakes :) )

Great you signed up :-) There is a first time for everything.


» Im wonder if there is an online course aboute bioequivalence (...)

I am reasonably well connected to regulatory bodies like EMA, NMAs, WHO, as well as people at USP, EDQM and a range of conference organizers.
I have suggested a million times that courses focusing on BE be available online or as targeted training. All people I talk to seem to like the idea very much. And all people I talk seem to believe someone else should be taking the action.

I have attended events focusing on BE and provided by people who came from the innovator side. They are generally disastrously bad. Innovator people are not humble, and the attitude is that if you know about innovator drugs then you know everything abuot BE because BE is just a quick and dirty type of innovator thinking. It is sometimes abysmal. I recall an event associated with the main AAPS confy in San Antonio 2013 where the guys at the panel tried to define BE universally but were oblivious to the fact that BE is not the same in EU as it is in US. And in stead of just admitting they had overlooked a detail which in the grand scheme of things is extremely important and a game-changer in terms of study types (PK vs PD) they were just clueless. I had to snort a tripple dose of my preferred tranquilizer "Crystal Schütz" that day.
Anyways, I can work with BE for 100 years without ever becoming a master of any degree. That is a positive challenge, too. I enjoy it.:-)

So you are right. We need training of all sorts, incl. online. It should be provided by the right people. If it isn't it will just not work.

In case you happen to be a regulator by some definition or other there may be opportunities for you in the not too distant future. In that case message me privately via the forum's mail function.

Pass or fail!
ElMaestro

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