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Dual Filing Strategies: How to Jointly Publish Marketing Applications for EMA and FDA

Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency.  Tips for … Continued

Adding Quality Control & Validation to Drug Discovery with AI

The proliferation of powerful AI models, including GPTs, has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. For example, by leveraging GPTs researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In addition, these … Continued

A Quantitative Systems Pharmacology Model to Study the Efficacy of Therapies for the Treatment of Autoimmune Disease

This webinar is hosted by the International Society of Pharmacometrics (ISoP) Speakers:  Abstract: The development of therapeutic antagonists that target BAFF and APRIL to treat autoimmune disease is still in its infancy, and many questions remain about their mechanisms of action and pharmacodynamic (PD) profiles, and how to optimize their efficacy. We developed a quantitative systems … Continued

Harmonize your Pharmacometric Workflows – An Introduction to Pirana

Unlock the full potential of your pharmacometric analysis with our introductory webinar on Pirana, the premier platform designed to enhance efficiency, organization, and performance in your pharmacometrics projects. Whether you’re new to Pirana or looking to optimize your workflow, this session is your first step towards mastering the tools and techniques that will transform your … Continued

Getting Started with Non-Linear Mixed Effects: Exploring Population Analysis with Real-Life Examples

Dr. Johan Gabrielsson, famed for his book “Pharmacokinetic and Pharmacodynamic Data Analysis,” collaborates with co-authors Drs. Bernd Wendt and Keith Nieforth from Certara on the forthcoming 6th edition. The new edition introduces an innovative chapter on population analyses using Non-Linear Mixed Effects models, enhanced by real-life case studies. Drs. Gabrielsson and Wendt will co-present a … Continued

How to Obtain Market Access and Reimbursement in the United States, France and Germany 【APAC Webinar】

The educational webinar will present the process of obtaining market access and reimbursement in the US, France and Germany as well as on the upcoming a Joint Clinical Assessment (JCA) process. In the US, we will be discussing the stakeholders that are involved in product access given the fragmented US payer system (e.g. Commercial, Medicare, … Continued

Visualizing SEND Data: Why and How

Nonclinical scientists in drug development have volumes of data to analyze and interpret. Visualization is a key tool in their toolbox, allowing for the detection of signals and outliers. SEND datasets are ideal for powering these visualizations. Learn how to turn this regulatory dataset into a engine for internal decision-making with SEND Explorer.

Access Phoenix anywhere: How to leverage the power of cloud computing to streamline PK workflows 

Compared to the Phoenix software installed on local computers, Phoenix Hosted gives research teams much better application performance, flexible access from PC or Mac environments, and comes pre-installed, pre-licensed, and pre-validated. Phoenix Hosted offers scalable hardware to any number of users in a personal workspace for each user. Teams can quickly adopt the latest version … Continued

Navigating the “Patent Cliff”: Omni-channel Strategies for Loss of Exclusivity and Established Products

When a pharmaceutical company faces the end of a product’s patent life, it encounters a myriad of challenges, including the need to overhaul its marketing and sales strategies. This session delves deep into these challenges, emphasizing how companies can pivot towards enhancing the marketing of their existing, patented products. The webinar will provide insights into … Continued

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