 
										eCTD Templates Page
Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
 
										Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
 
										This blog explains how oligonucleotide therapeutics work and compares them with small molecule and biologic drugs.
 
										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...
 
										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 (...)
 
										For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG).
 
										Certara’s Secondary Intelligence | Predict and analyze off-target risks in drug development for safer outcomes.
 
										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)...
 
										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...
 
										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