Dear Dimitri While I am a member of an ENCEPP centre, I was an Expert member of PRAC at the EMA for its first six years. I would not recommend consulting any EnCePP centre regarding the regulatory issues. they can be good at carrying out the studies. ...
Thank you Thamir. Probably there is no such document and a good point that pass can be interventional as well (PEpi won't do pass in this case but most likely will collaborate with a clnical/other teams leading such interventional pass study). Thank ...
Thank you Nicholas, much appreciated !! Happy New Year !! ------------------------------ Dimitri Bennett MD, MPH, FISPE, FACE Takeda Pharmaceuticals International Cambridge MA (617) 444-3339 ------------------------------