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Stay on Track and Get Some Sleep: Marketing Application Best Practices

Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone to falling off track and costing valuable time and resources… and sleep. In this webcast, you’ll learn best practices for a marketing application submission which can be a significant undertaking. Regulatory experts will offer tips and guidance for acceleration, submission … Continued

COVID-19 Pharmacology Online Resource Center with Dr. Craig Rayner

Health Professional Radio – Podcast Dr. Craig Rayner, president of Certara’s Integrated Drug Development and Strategic Consulting Services discusses the COVID-19 Pharmacology Online Resource Center funded by the Bill & Melinda Gates Foundation and the programs they are working on to accelerate the treatment for COVID-19.

Good Practices in Model-Informed Drug Discovery and Development with guests Scott Marshall, Sandra Visser, and Amy Cheung

ASCPT Podcast In this episode, Drs. Scott Marshall from Pfizer, Sandra Visser from Merck, and Amy Cheung from AstraZeneca discuss “Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation”: their White Paper published in the March 2016 issue of PSP. You can get free access the White Paper by clicking here.

“Thoughtflow” with guests Mike Smith, Justin Wilkins, and Amy Cheung

ASCPT – Podcast On today’s episode, Mike Smith from Pfizer, Justin Wilkins from Occams, and Amy Cheung from AstraZeneca discuss “Thoughtflow”, a set of standards compiled by the DDMoRe consortium to help facilitate the capture, storage, and reporting of knowledge in the context of MID3, as well as to support reproducibility.

Food and Drug Administration Renews and Expands Use of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

FDA’s Office of Pharmaceutical Quality adds new licenses of Simcyp™ Simulator PRINCETON, N.J.—2020年10月1日. Certara, a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has again renewed and expanded its licenses of Certara’s biosimulation software, with more than 400 user licenses of Simcyp™ and Phoenix™ platforms. Eleven divisions … Continued

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