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
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
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
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
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
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
Discover the latest advancements and enhancements in Phoenix version 8.5 in our upcoming webinar. Uncover the key release themes, including significant upgrades to reporting functionalities with improvements in Tables, Plotting, and Reporter modules. Learn about the streamlined licensing process utilizing Certara Central Administration and explore the NLME enhancements that empower your modeling and simulation endeavors. … Continued
Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies. For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can … Continued
Unlock the full potential of your pharmacometric analysis with our introductory webinar on Pirana, the premier platform designed to enhance efficiency, organization, and performance in your pharmacometrics projects. Whether you’re new to Pirana or looking to optimize your workflow, this session is your first step towards mastering the tools and techniques that will transform your … Continued
Dr. Johan Gabrielsson, famed for his book “Pharmacokinetic and Pharmacodynamic Data Analysis,” collaborates with co-authors Drs. Bernd Wendt and Keith Nieforth from Certara on the forthcoming 6th edition. The new edition introduces an innovative chapter on population analyses using Non-Linear Mixed Effects models, enhanced by real-life case studies. Drs. Gabrielsson and Wendt will co-present a … Continued
