Medical Affair, Market Access, and Sales &amp; Marketing teams at most of pharmaceutical companies use PowerPoint or Interactive PDF to explain value of new drugs. They are struggling with how to keep the content up-to-date across the organization and how to accurately share real value in limited time with each stakeholder. Certara’s BaseCase helps you &hellip; <a href="https://www.certara.com.cn/webinar/how-digital-communication-tools-will-revolutionize-your-medical-conversation/">Continued</a>

Published research and literature-based content holds valuable insight that can inform clinical trial execution and outcomes. While rich with data, this content is unfortunately very challenging to effectively analyze.&nbsp;&nbsp;&nbsp; Clinical meta-analysis addresses this challenge by extracting, combining and normalizing clinical trial results from a range of data sources that can be used to draw conclusions &hellip; <a href="https://www.certara.com.cn/webinar/transforming-trial-success-ais-role-in-clinical-trial-meta-analysis/">Continued</a>

Mechanistic modeling approaches like Quantitative Systems Pharmacology (QSP) and Physiologically-Based Pharmacokinetics (PBPK) are increasingly used to make biopharmaceutical R&amp;D more efficient and effective and to improve regulatory decision making.&nbsp; QSP modeling workflows involve developing a Biological Map which captures the expert opinions on the mechanistic details of the model to be developed, followed by implementation &hellip; <a href="https://www.certara.com.cn/webinar/qsp-and-simcyp-designer-seamless-and-user-friendly-integration-of-qsp-and-pbpk-models/">Continued</a>

Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic Drugs

On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in … Continued

Access to safe and effective medications is critical for pediatric patients, yet 60-70% of medicines prescribed to children are off-label. In Japan, only 30% of new drugs are approved for pediatric use. Unlike the US and the EU, Japan has no regulation mandating pediatric drug development. Still, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has … Continued

A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it helps sponsors identify and address potential Market Access, Pricing & HEOR (health economics outcomes research) barriers that could affect the launch and commercial success of their product. The GRMP typically consists of two parts: a Risk Assessment Tool and a … Continued