ElMaestro ★★★ Denmark, 2014-07-15 19:17 (3565 d 17:39 ago) Posting: # 13268 Views: 1,458 |
|
Hi all, new regulation from CDSCO: Link here. This could quickly get complicated to the point where companies are seeking ways to game the system. When is a PI involved in the conduct?
If an Indian generic company conducts a trial outside India, must the Indian company then ensure that the PI wherever (s)he works is still observing this regulation? — Pass or fail! ElMaestro |
Ohlbe ★★★ France, 2014-07-15 19:52 (3565 d 17:04 ago) @ ElMaestro Posting: # 13269 Views: 1,271 |
|
Dear ElMaestro, It is indeed very unclear to me and raises tons of questions:
— Regards Ohlbe |