In pharmacovigilance and in this industry largely, striking a regulatory balance undeniably precedes over anything else. If you are not regulatory compliant, you might be outmoded.
Industry’s competence parameter is not only the quality of the products they are marketing but also how well and how quick they are taking a call for regulatory compliance!
Transition that needs to be addressed…
Industry was just trying to overcome and streamline the gigantic revolution of xEVMPD. As if it was just the beginning of yet another principal leap, Regulator’s announcement of transition to ISO standards became the next breaking news for Industry.