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Evidence generation in Europe- How valuable is the French National administrative health data (SNDS) On-Demand Webinar

Watch this presentation to learn • Overview of the SNDS and the key working practices to access the database and ongoing SNDS developments • Similarities and differences between SNDS and other claims databases • Strengths and opportunities for HTAs and...

Early Engagement with HTA Bodies Brochure

In-depth guide to successful early HTA engagement.

Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics Publication

Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced surveillance systems for early threat detection will be crucial to maximizing response time for implementation of public health measures (...)

Model-informed Vaccine Development Page

For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG).

Secondary Intelligence Page

Certara’s Secondary Intelligence | Predict and analyze off-target risks in drug development for safer outcomes.

Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate Publication

As model‐informed drug development becomes an integral part of modern approaches to the discovery of new therapeutic entities and showing their safety and effectiveness, modalities of incorporating the paradigm into widespread practice require a revisit. Traditionally, modeling and simulation (M&S)...

Why Your Regulatory Writers Need eCTD Authoring Templates Blog Post

If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an...

PBPK modeling approaches to assess risks associated with bioequivalence in drug development On-Demand Webinar

In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalenceIVIVE-PBPK in biopharmaceuticsAn quantitative risk assessment approach for virtual bioequivalenceRole of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence

Overview of SNDS and the key working practices to access the database and ongoing SNDS developments On-Demand Webinar

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe....

Using Authoring Templates to Write the Right Way On-Demand Webinar

Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to be eCTD compliant the first time comes with its unique challenges. To address these challenges, Certara Synchrogenix paired its technical experts with its regulatory writers...

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