EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-03 20:23 (879 d 04:04 ago) – Posting: # 21133
Views: 3,542

Thanks Ohlbe!

» When I read your post I interpreted it differently than Helmut and ElMaestro. So could you clarify your question: would you run those studies to register your drug in Europe, or to register it in the USA ? Helmut and ElMaestro answered with EU registration in mind, I understood you were asking about the authorisation of the studies.

Purely a exploratory study for the interest of science. No registration no drug submission. The drug is marketed in US (IR + ER), IR is available all over the world.

» Being based in the USA, you would need a legal representative in the EU.

Agree.

» You will need to justify in your protocol (subject safety) and plan the monitoring of the subjects accordingly.

Yes the protocol will implement a lot of medical monitoring, blood chemistry testing, etc. Subjects will be housed in clinic for the entire study.

Thx
J

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