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The Neuroplatform: Towards a Comprehensive Mechanistic QSP Model of Alzheimer’s Disease for Supporting Drug Discovery and Development

With over 55 million people diagnosed worldwide, Alzheimer’s disease presents a significant public health challenge, with treatment costs and caregiver burden reaching staggering figures, expected to exceed a trillion dollars soon. Explore the latest insights into Alzheimer’s disease and drug development in Dr. Hugo Geerts’ presentation at the University of Indiana. Learn about the development … Continued

Optimizing the Quality of CDISC SDTM Compliance [APAC Webinar]

Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end? A retrospective … Continued

Closing the Loop: How to Improve the Management of Your Design-Make-Test-Analyze Cycle

Scientists in drug discovery often spend excessive time managing research data instead of concentrating on identifying the most promising compounds for new drugs. The right technology streamlines the drug discovery process, providing a seamless workflow for data-driven design, analysis, and research tracking of small molecules. In this webinar, experts from Certara and Chemaxon will guide … Continued

eCTD 4.0: New Standard, New Technology, New Opportunities

The eCTD v4.0 standard introduces several changes to the submission process, including updated granularity, context groups, re-used files, and more. The change will require new habits and new technology, but one upside is better harmonization across regulatory agencies. Join our webinar to discuss some of the nuanced changes in the v4.0 standard and discover how … Continued

The State of AI in In Silico Trials and Drug Development – The Practical Application of AI in QSP [APAC Webinar]

The proliferation of AI models and GPTs has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. By leveraging GPTs, researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In this webinar, Certara’s experts will … Continued

Dual Filing Strategies: How to Jointly Publish Marketing Applications for EMA and FDA

Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency.  Tips for … Continued

Adding Quality Control & Validation to Drug Discovery with AI

The proliferation of powerful AI models, including GPTs, has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. For example, by leveraging GPTs researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In addition, these … Continued

A Quantitative Systems Pharmacology Model to Study the Efficacy of Therapies for the Treatment of Autoimmune Disease

This webinar is hosted by the International Society of Pharmacometrics (ISoP) Speakers:  Abstract: The development of therapeutic antagonists that target BAFF and APRIL to treat autoimmune disease is still in its infancy, and many questions remain about their mechanisms of action and pharmacodynamic (PD) profiles, and how to optimize their efficacy. We developed a quantitative systems … Continued

What’s New in the Simcyp™ Simulator – from Regulatory Advances to New Modalities

Already the most sophisticated technology for physiologically based pharmacokinetic modeling (PBPK), the Simcyp Simulator has added a range of new advances in its recently release (version 23).  This webinar, hosted by the subject matter expert scientists at Simcyp, will share these new capabilities and review the features that have enabled the Simulator to be leveraged … Continued

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