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Episode 8: Performing clinical trials in a shifting development landscape
Manage episode 258392742 series 2618437
The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new realities? What new behaviors should we adopt to sustain progress? What are the new best practices when working with regulatory authorities, with clinical sites, and with each other?
41 episode
Manage episode 258392742 series 2618437
The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new realities? What new behaviors should we adopt to sustain progress? What are the new best practices when working with regulatory authorities, with clinical sites, and with each other?
41 episode
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