pre-update Archives

Video

Your First Choice in Complex Biologics Drug Development

The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide…

CertaraJune 1, 2021

On-Demand Webinar

De-risk your program with evidence-based secondary pharmacology insights

Safety issues account for about a quarter of the attrition in drug projects and can…

CertaraMay 28, 2021

On-Demand Webinar

Stakeholder perspectives: current and potential benefits

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

CertaraMay 26, 2021

On-Demand Webinar

Strengths and opportunities for HTAs and market access in Europe through case studies

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

CertaraMay 26, 2021

On-Demand Webinar

Similarities and differences between SNDS and other claim databases

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

CertaraMay 25, 2021

On-Demand Webinar

Using Authoring Templates to Write the Right Way

Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to…

CertaraMay 25, 2021

On-Demand Webinar

Overview of SNDS and the key working practices to access the database and ongoing SNDS developments

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

CertaraMay 25, 2021

On-Demand Webinar

PBPK modeling approaches to assess risks associated with bioequivalence in drug development

In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting…

CertaraMay 19, 2021

Blog

Why Your Regulatory Writers Need eCTD Authoring Templates

If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…

CertaraMay 14, 2021

Publication

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

As model‐informed drug development becomes an integral part of modern approaches to the discovery of…

CertaraMay 13, 2021

pre-update

Your First Choice in Complex Biologics Drug Development

De-risk your program with evidence-based secondary pharmacology insights

Stakeholder perspectives: current and potential benefits

Strengths and opportunities for HTAs and market access in Europe through case studies

Similarities and differences between SNDS and other claim databases

Using Authoring Templates to Write the Right Way

Overview of SNDS and the key working practices to access the database and ongoing SNDS developments

PBPK modeling approaches to assess risks associated with bioequivalence in drug development

Why Your Regulatory Writers Need eCTD Authoring Templates

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

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