In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.
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In this Denatured episode, Jennifer C. Smith-Parker speaks to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We discuss about how the FDA’s move from two to one pivotal study for new drug applications sets a higher benchmark for data collection and risk-based management.
Host
Jennifer C. Smith-Parker, Director of Insights, BioSpace
Guests
Oxana Iliach, Senior Director of Regulatory Strategy, Certara
Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
