Drug Submissions Relying on Third-Party Data/Literature based submissions for prescription medicines: An update

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This session will focus on literature- based submissions for new drugs in Canada and prescription medicines in Australia. Topics that will be covered are as follows:

Overview of process (similarities and differences between jurisdictions)
Experience to date with illustrative case studies
Considerations
Future directions

Please note that this is an exhibitor sponsored event and is not eligible for CE credit.

Presenter:

Mary Speagle, Senior Director, Regulatory Affairs, TPIreg, a part of Innomar Strategies

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