On-Demand Webinar Archives

On-Demand Webinar

What you should know about FDA Project Optimus for your oncology drug approval

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…

CertaraMarch 10, 2023

On-Demand Webinar

RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes

Oops, I made a mistake! Everyone has made or seen one, and sometimes it is…

CertaraMarch 9, 2023

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…

CertaraMarch 1, 2023

On-Demand Webinar

FDA Modernization Act 2.0 – What does it mean for drug developers?

Historically, the FDA has required drug discovery and development programs to include animal testing. This…

CertaraFebruary 21, 2023

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…

CertaraFebruary 10, 2023

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…

CertaraFebruary 9, 2023

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…

CertaraFebruary 3, 2023

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…

CertaraJanuary 20, 2023

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…

CertaraJanuary 13, 2023

On-Demand Webinar

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…

CertaraDecember 5, 2022

On-Demand Webinar

What you should know about FDA Project Optimus for your oncology drug approval

RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes

Learn how to create CDISC domains in minutes with PK Submit

FDA Modernization Act 2.0 – What does it mean for drug developers?

RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act

Data Visualization with SEND Data to See What Happened at the Preclinical Phase

Machine learning model selection with Darwin in Pirana

D360 as your organization’s extendable and central data engine

Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

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