RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes On-Demand Webinar RAPS協賛Webcast: またやっちゃった!一般的な規制当局への提出書類におけるミスを回避(および修正)する方法 うっかりミス、誰にでも起こり得ます。Everyone has made or seen one, and sometimes it is…Danielle Pillsbury2023年3月9日
Learn how to create CDISC domains in minutes with PK Submit On-Demand Webinar Learn how to create CDISC domains in minutes with PK Submit Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be…Danielle Pillsbury2023年3月1日
FDA Modernization Act2.0:創薬研究者はどこに注目すべきか? オンデマンド・ウェビナー FDA Modernization Act2.0:創薬研究者はどこに注目すべきか? 歴史的に、FDAは新薬の発見と開発プログラムに動物実験を含めることを義務付けてきました。This…Danielle Pillsbury2023年2月21日
RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act On-Demand Webinar RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and…Danielle Pillsbury2023年2月10日
Data Visualization with SEND Data to See What Happened at the Preclinical Phase On-Demand Webinar Data Visualization with SEND Data to See What Happened at the Preclinical Phase SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation…Danielle Pillsbury2023年2月9日
Machine learning model selection with Darwin in Pirana On-Demand Webinar Machine learning model selection with Darwin in Pirana Discover how to enhance machine learning model selection with Darwin in Pirana. Watch this on-demand…Danielle Pillsbury2023年2月3日
D360 as your organization’s extendable and central data engine On-Demand Webinar D360 as your organization’s extendable and central data engine D360 is an industry-leading scientific data informatics platform providing a flexible, scalable, and customizable enterprise…Danielle Pillsbury2023年1月20日
Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label On-Demand Webinar Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label Physiologically based pharmacokinetic (PBPK) modeling and simulation has become an established approach to assess drug-drug…Jim Gallagher2023年1月13日
Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges On-Demand Webinar Therapeutic Proteins’ Drug-Drug Interactions: 最新情報および課題 Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…Becca Bucci2022年12月5日
Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations On-Demand Webinar Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations Over the past two decades, there have been transformative changes in our approach to using…Danielle Pillsbury2022年10月20日