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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.

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