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Jan 10, 2025 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A defect in the Frataxin (FXN) gene causes FA. FXN is essential for the proper functioning of the mitochondria, and its deficiency leads to mitochondrial dysfunction, oxidative stress, and neuroinflammation. Patients develop ataxia, balance issues, loss of motor skills, speech impairment, weakness, visual impairment, and sensory loss. Patients with FA also have diverse non-neurological features.
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Jan 7, 2025 | 
certara.com | Danielle Pillsbury
The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for Human Use, commonly known as EMA’s Policy 0070, requires drug companies to proactively share the results of their clinical trials in the public domain after receiving a Marketing Authorization Application (MAA) decision from EMA.
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Jan 6, 2025 | 
certara.com | Danielle Pillsbury
Generative AI (GenAI) is poised to revolutionize writing and report generation. In fact, industry studies have shown the use of GenAI can introduce efficiencies of up to 40% while providing the tools needed to provide a happier writing team. However, successful implementation of a GenAI tool within your medical or regulatory writing team doesn’t start and end with deployment of a new software.
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Jan 6, 2025 | 
certara.com | Danielle Pillsbury
Faced with more and more complex clinical research than ever before, regulatory writers are facing new demands. Along with eCTD structural mastery, writers must bring to their task data integration skills, consistent approaches to explanation, and a collaborative spirit. AI-powered writing software, CoAuthor™, helps your writing team to accelerate the drafting and submission of quality and compliant regulatory documents.
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Jan 3, 2025 | 
certara.com | Danielle Pillsbury
Moxidectin for Women’s Health EquityModel-Informed Drug Development is increasingly impacting public health and regulatory decision-making in support of global health initiatives. In this webinar, we will share a recent global health case study on the use of pharmacokinetic (PK) and physiologically based pharmacokinetic (PBPK) modeling of moxidectin to understand the impact of drug exposure on breastfed infants.
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Dec 10, 2024 | 
certara.com | Danielle Pillsbury
In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the quality and consistency of pharmaceutical products. The quality portion of a submission (such as an IND, NDA, BLA, MAA, etc.) varies in complexity based on the synthesis route of the drug substance/active pharmaceutical ingredient (API) and the type of drug product (oral solid, oral liquid, topical, parenteral, etc.).
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Dec 5, 2024 | 
certara.com | Danielle Pillsbury
Join us for an exclusive sneak preview of the upcoming Tables, Figures, and Listings (TFL) Module in Phoenix Cloud. Discover how this innovative tool will revolutionize the way you create and manage TFLs, providing faster results, enhanced flexibility, and streamlined collaboration. During this webinar, you’ll explore key features such as: Pre-built and Custom Templates: Create multiple TFLs simultaneously with tailored templates.
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Dec 4, 2024 | 
certara.com | Danielle Pillsbury
Home / Resources / Conferences / Antibody Engineering & Therapeutics We are excited to be presenting at this conference Add to calendar Apple Google (online) Office 365 (online) Outlook Outlook.com (online) Yahoo (online) Bridging the in vitro to in vivo Gap for T-cell Engagers Using QSP Modeling David Flowers, PhD, Director at Certara The unique cell-to-cell crosslinking action of T-cell engagers (TCEs) poses challenges for in vitro to in vivo translation.
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Nov 22, 2024 | 
certara.com | Danielle Pillsbury
What are clinical metadata repositories (CMDRs) and how do they lead to faster trial build and submission? A clinical metadata repository can drastically simplify and speed up the clinical study process, by creating efficiencies in every aspect of study build, from design to submission. By implementing a CMDR, organizations can access functionality that is crucial to the effective running of clinical trials.
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Nov 22, 2024 | 
certara.com | Jen Moyers |Danielle Pillsbury
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and involved clearly defined roles. The writers wrote all the non-clinical and clinical documentation, and then the reviewers reviewed it. With the advent of collaborative authoring technology, that process went by the wayside. Initial drafts are frequently written in collaboration with team members who would have previously been classified in a review role.
