Webinars

Why is RWE gaining increasing importance not just from a payer perspective but also from a regulatory perspective? The FDAs new strategic framework to advance the use of RWE to support the development of drugs and biologics has recently been issued. This...

In recent times, there has been a significant surge in the use of Real World Evidence (RWE) for making informed healthcare decisions. This webinar offers a unique perspective on the current state-of-the-art applications of RWE by stakeholders like regulators and payers. It...

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...