Certara

Are you ready for eCTD 4.0? Don't get left behind! Join our webinar to explore the new submission structure of eCTD 4.0 and discover how the right software can make the transition to eCTD v4.0 easy. Register now: https://lnkd.in/eZcgPcjK #eCTD #cloud #software #technology #regulatory #submissions #lifescience #regulatoryaffairs #regops #regulatorytechnology #regulatorycompliance #pharmaceutical #efficient #EMA #FDA

Country-specific policies on reimbursement, pricing and patient access play a major role in the successful commercialization of digital health innovations in Europe. Our latest white paper "Digital Health Technologies: Market Access, Reimbursement & Pricing" details regulations governing market access for DHTs in seven (7) European countries and offers Certara's expert recommendations for obtaining sustainable reimbursement. Read more: https://ow.ly/8sHv50SAmzl #DigitalHealth #RegulatoryCompliance #MarketAccess #Reimbursement #EMEA #HealthTechnologyAssessment #HTA

Developing analytical procedures for cell and gene therapy (CGT) products can be tricky. Our CMC experts offer solutions for product characterization, release testing, and overcoming limited sample size with techniques like rapid testing methods and next-generation sequencing. Check out this informative article to learn key strategies: Read more: https://ow.ly/gokm50Se6c6 #CellAndGeneTherapy #CMC #PharmaceuticalManufacturing #Pharmaceutical #DrugDevelopment #Pharma #PharmaceuticalAnalysis

Everyone agrees there's high anticipation around AI's impact in drug development. However, in order for AI to reach its full impact in drug development, it's not as easy as tossing searches into ChatGPT. The successful application of AI to drug development requires expertise in knowing how best to incorporate AI into research as well as technology that appropriately integrates AI with other in silico approaches, such as QSP and PBPK. This article by Amin Rostami-Hodjegan and Piet Van Der Graaf demonstrates the various applications of AI to drug development currently implemented at Certara. View the full article at: https://ow.ly/Z8TM50SAqK8 #AI #DrugDiscovery #DrugDevelopment #QuantitativeSystemsPharmacology #PBPK

When should you level up to Pinnacle 21 Enterprise? ⏫ In this blog, we answer P21 Community users’ questions about the differences between Community and Enterprise, before answering the ultimate question: when is the right time to upgrade? Read the blog here: https://lnkd.in/eajBt2gd #Certara #ClinicalData #ClinicalDataManagement #ClinicalDataValidation

Unlocking Insights in Biopharmaceutics: Simcyp’s Webinar Recap The field of physiologically based pharmacokinetics (PBPK) is rapidly expanding, and Simcyp Biopharmaceutics is at the forefront. Our Platform has extensive suite of features and scientific tools —from mechanistic modeling to IVIVC (in vitro-in vivo correlation) and VBE (virtual bioequivalence). In our recent webinar, esteemed industry experts—Vivek Purohit, Kazuko Sagawa, and Ioannis Konstandtinidis—shared their wealth of experience with small molecule model-informed formulation development (MIFD). They covered critical topics, including early formulation selection and VBE assessments. 📺 Watch the Webinar: https://ow.ly/uGxo50Szh4G Learn more about Simcyp Biopharmaceutics and discover our robust consulting services. #PBPK #Biopharmaceutics #DrugDevelopment #MIFD #IVIVC #VBE #WebinarInsights #Pharmacokinetics #FormulationDevelopment #SimcypBiopharmaceutics #PBPKConsulting

Navigating eCTD 4.0? We've got you covered! The eCTD v4.0 standard brings significant changes, including the use of keywords in metadata and the introduction of a new harmonized submission unit .xml. These updates present the familiar eCTD modules in a whole new light. Join our webinar to explore the new submission structure of eCTD 4.0 and discover how the right software can make the transition to eCTD v4.0 easy. Register now: https://lnkd.in/eZcgPcjK #eCTD #cloud #software #technology #regulatory #submissions #lifescience #regulatoryaffairs #regops #regulatorytechnology #regulatorycompliance #pharmaceutical #efficient #EMA #FDA

Attention Pharmaceutical Scientists Curious About PBPK Approaches! If you’re interested in Physiologically-based Pharmacokinetic (PBPK) modeling, mark your calendar for the #2024ACCP Annual Meeting! Certara’s Senior Vice President and Head of PBPK Consulting, Hannah Jones, PhD. will be sharing valuable insights in two presentations: 1. “Interspecies Scaling Approach Using PBPK Modeling” 2. “Prediction of Formulation Effects & Clinical Drug-Drug Interactions Using PBPK Modeling” These talks are part of the PMWS (Physiologically-based Pharmacokinetic Analyses: Practical Applications in Clinical Drug Development) session on September 7, 2024. To learn more about ACCP and to register, visit: https://lnkd.in/ejbWKB-n #ClinicalPharmacology #DrugDevelopment #HealthcareEducation

Exciting News: Certara to acquire Chemaxon a leader in cheminformatics software! Our combined organization brings broader predictive capabilities to the drug discovery biosimulation market at scale. Together, we aim to transform drug development from discovery through commercialization with improved decision-making that helps bring breakthrough medicines and new treatments to patients faster. #DrugDiscovery #Cheminformatics #Biosimulation #PharmaInnovation Learn more: https://ow.ly/rXHa50SykPO

Save the date! 📅 Our annual client event, Certainty by Certara, is coming to Europe for the first time this fall! https://lnkd.in/ejDR83h5 Join us 29-30 October 2024 in Mainz, Germany for an engaging event where experts and scientists in biosimulation, clinical pharmacology, regulatory science, AI, and software development will come together to share strategies, best practices, and lessons learned for improving greater certainty in drug development.   The areas of expertise and session themes include: - Biosimulation for improved success across the development lifecycle - Digital data flows from protocol design through approvals - The value of Model Informed Drug Development from discovery to first in human - Applying Generative AI to solve drug development challenges For our power technology users interested in learning about the latest features available in the Certara platform, we are offering one-day user group meetings on Wednesday, 30 October for Phoenix️™ and Pinnacle 21. Learn more and reserve your spot: https://lnkd.in/ejDR83h5 We can't wait to see you in Mainz! #CertaintyEurope #CertaraCertainty #DrugDevelopment