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In the wake of the COVID-19 pandemic, governments across the globe have rushed to implement countermeasures and develop best practices to curtail the spread of the virus, impacting the conduct of clinical trials in unprecedented ways. As a result, regulatory authorities quickly developed and continue to refine guidance on conducting clinical research in this very challenging environment.
In this complementary webinar, MMS regulatory experts discuss changes pharmaceutical companies should consider implementing in response to COVID-19. They focus not only on changes to study-related documents recommended by regulatory authorities, but other aspects affecting trials, including:
- the potential need for increased pharmacovigilance,
- how to provide for and manage additional study vendors,
- the potential for remote auditing,
- preparing for additional requirements in personnel training, and
- what all of these changes mean to regulatory strategy.
Attendees will learn how to move clinical trials forward during the pandemic while ensuring complete regulatory compliance.
Presenters:
Barbara A. Rusin, Senior Regulatory Compliance Manager, MMS
Ben Kaspar, Global Regulatory Affairs Manager, MMS
