Brickwalls do you mean in relation to the SAWP meeting?
Hopefully I have the following correct. Any amendments are most welcome.
-TIS deal directly with SAWP experts (appointed by EMA's CHMP committee) who give advice at meeting on best way to answer remaining CHMP committee questions (though the advice is not guaranteed to be foolproof). I think the CHMP review committee chair is allowed to attend SAWP.
-SAWP experts report on discussions with TIS to CHMP committee this week (EMA talking to EMA)
-CHMP committee will accept plan or recommend amendments or come up with more questions several weeks later (April?) which I assume will be communicated through BSI (Notified Body) to TIS???? as will TIS's responses???? Then maybe they have further SAWP meetings and the process repeats, hopefully on a monthly basis.
Then TIS do their data gathering over X months and submit results via BSI to CHMP committee under another 210 day review with hopefully very few new questions if any.
So in a nutshell: TIS talks directly to SAWP but only through BSI to CHMP committee (except apparently when there is an oral explanation - which appears to me to be basically a one off discussion with CHMP members as to why they weren't getting anywhere but who knows).
Are TIS obliged, inclined or financially committed to using BSI as their Notified Body? Anyone know?
TIS Price at posting:
7.0¢ Sentiment: Hold Disclosure: Held
