DIA MASC Conference
Hear our experts speak about the Direct Use of AI in Clinical Regulatory Document Development: Real-World Use during DIA MASC 2024.
Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence Publication
The extent of cross-protection provided by currently licensed bivalent and quadrivalent HPV vaccines versus direct protection against HPV 31-, 33-, 45-, 52-, and 58-related disease is debated. A systematic literature review was conducted to establish the duration (...)
Purity is a Virtue: A Practical Guide to the Reporting of Impurities On-Demand Webinar
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA)...
Document Quality and Management Page
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Strategic Evidence & Value Communication Symposium On-Demand Webinar
Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara's first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
Legislators: Bring all stakeholders to the table to lower drug costs Press Coverage
BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who represent them, not physicians, not insurance payers and not drug...
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure On-Demand Webinar
The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. ...
Getting started with in-house development: how does it work? Blog Post
Learn how in-house app development with BaseCase enables rapid creation, centralized management, and unmatched flexibility to communicate product value.
