Webinars

EMA went live with a new and improved EudraVigilance database which was accompanied by updates to GVP Module VI (ICSR and Safety Reporting) and Module IX (Safety Signal Management). While the attempt to harmonize and standardize safety processes is welcomed, some functionality...

Real World Data (RWD) is defined as data collected outside the controlled constraints of conventional randomized clinical trials to evaluate what is occurring in routine clinical practice. One of the characteristics of RWD is large sample size along with heterogeneity which needs...

EMA will be releasing a revised GVP module VI in the near future and R3 has been widely discussed for several years and will be implemented this year. Each of these changes is likely to have a significant impact on safety and...

In the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market. Compared to new products,...

Warning letters are issued by the US FDA when, based on available evidence, it has found that an organization has violated a specific rule in a regulated activity. While they are characteristically informal and advisory, their ultimate aim is to establish voluntary...