Interpretation of New Pharmacovigilance Regulations: Key Insights

Key Takeaways

New pharmacovigilance regulations in the US will have a dramatic impact on safety reporting for clinical trials and represent a major paradigm shift in clinical research oversight.
Through the expertise of its 20 member companies, TransCelerate is conducting numerous initiatives to help sponsors successfully navigate and implement new pharmacovigilance guidelines.
Although companies are generally complying with the 2010 final rule limiting the submission of serious adverse event reports, there has been a significant decrease in the amount of events reported to the FDA.
Developing a cross-disciplinary team to implement changes in regulatory processes enables colleagues across an organization to speak the same language, regardless of function.