This Solution Provider Webinar is brought to you by DIA in cooperation with
Sciformix Corporation

It has been several years since GVP module VI went into effect, and at the end of 2016 EMA closed the public consultation for the proposed changes. EMA will be releasing a revised GVP module VI in the near future. In addition, 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 pharmacovigilance operations. This webinar will detail how these guidelines and regulations are being viewed in different organizations and how they may impact your own safety operations.

In December 2015, FDA released a draft guidance on safety assessment for IND safety reporting in support of the changes in the IND safety reporting regulations. These recommendations have presented challenges for many organizations and this webinar will give a perspective from a company that has worked with FDA to implement the key elements of the guidance.