Greater Certainty in Drug Development

Free Webinar for Biopharmaceutics and Drug Formulation Scientists Join us for an insightful discussion with Pfizer experts Vivek Purohit, Sr. Director and Pharmacometrics Team Leader for Inflammation and Immunology, and Kazuko Sagawa, Research Fellow in the Biopharmaceutics Group, along with Ioannis Konstandtinidis, Principal Scientist II Modeling &amp; Simulation, PK Sciences at NIBR at Novartis. We&#8217;ll &hellip; <a href="https://www.certara.com/webinar/from-concept-to-market-value-of-mifd-simcyp-biopharmaceutics-for-streamlined-drug-formulation-and-approvals/">Continued</a>

This webinar will be held in Japanese only. Medical writing is a critical part of drug development. It relies on manual processes which have not changed significantly over the past two decades. Drug development pipelines increasingly comprise precision medicine therapies that depend on advanced biomedical knowledge. Today’s medical writers must translate complex study designs and &hellip; <a href="https://www.certara.com/webinar/how-ai-powered-writing-software-can-bring-a-benefit-in-japan-japan-webinar/">Continued</a>

In the field of biopharmaceuticals, non-clinical data, including data from single and repeat-dose toxicity, genotoxicity, carcinogenicity, reproductive juvenile toxicity, local tolerance, and more, is an essential and valuable resource for drug development. However, efficiently parsing this vast amount of data and making informed decisions based on it has always posed a challenge for the industry. &hellip; <a href="https://www.certara.com/webinar/unlocking-the-data-puzzle-of-preclinical-drug-development-send-explorer-data-visualization-pinnacle-21-enterprise-compliance-validation-and-issue-management-china-webinar/">Continued</a>

Streamlining Clinical Trials and Drug Discovery with AI  The drug development landscape is evolving with the introduction of Generative AI (GEN AI), offering unparalleled opportunities for innovation and efficiency. Generative AI technology uses natural language processing (NLP) to create new text from existing data.   This Axendia Market Research Report: “The State of Generative AI in … Continued

New therapeutics development in rare diseases presents both opportunities and complexities. Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration. The top 3 critical downfalls in rare diseases development include Poor understanding of … Continued

Categorizing Risks  From a sponsor’s first authorization to conduct a clinical drug trial in any country worldwide, they must prepare and submit development safety update reports (DSURs) annually. The purpose of the DSUR is to present a comprehensive evaluation of safety information related to the sponsor’s investigational drug.1   A mandatory part of this safety evaluation … Continued

Advances in technology and changes to the regulatory environment have resulted in a change in drug applications, from being comprised of a collection of randomized clinical trials (RCTs) to RCTs plus real-world data (RWD) and data from various non-interventional study designs.   Most New Drug Applications (NDAs) and Biologics License Applications (BLAs) that were approved in … Continued

Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand scientific concepts and the latest regulations and guidelines to produce compliant regulatory documents. As a result, writing the documents required for a drug program can be time-consuming and prone to delays.  Over the past two decades, regulatory writing practices have … Continued