India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
Pharmacovigilance Audits
GVP Modules III and IV published in December 2012
Two new GVP modules were published in December 2012, Module III - Pharmacovigilance Inspections and Module IV - Pharmacovigilance Audits, bringing the total of final modules to nine. It is expected that the remaining modules will be finalised and published in 2013....