Medicon Valley Alliance and Lumis Life Science Consulting GmbH are pleased to invite you to an online Good Morning Meeting on the 26th of January 2023, focusing on the optimization of scientific clinical plans, clinical vendor management and contracting. With rapidly changing standards of care, the appropriate clinical study design can be a moving target. […]

One of the major recent trends in drug development in oncology, particularly with highly targeted therapy and immunotherapy, is a great concern with efficacy assessment in early phases of development. This was not frequent before the era of precision medicine. As a result, phase 1 trials now routinely have efficacy endpoints and even sample-size justification […]

– an international outlook and regional challenges  Hologic Global Women’s Health Index is a unique survey based on 120 000+ interviews representing 2.5 billion women and girls. Using the index as a starting point, we discuss possible ways forward for Swedish and Danish women’s health – with a focus on cancer prevention. How can we mitigate the impact […]

Join us for this live webinar to learn about Molecular Classification-based identification of diagnostic and treatment targets in glioma. Dr. Xiaolong Fan, professor at Beijing Normal University in China will provide a high-level overview of his experience in dealing with the challenges of this project. His team has been pursuing this project for about 15 […]

The ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. Why should you have a QMS in the first place, and why use the ISO 13485 standard? We’ll share hands-on experience on what the standard means in practice, as well as ideas on how you can ensure […]

– tackling two of the most intensely regulated pathways in one go   Combination products are a fast developing market but a tricky one. Yet this market is really picking up speed. New technologies enable patient care in ever improving levels. But how do you tackle two of the most intensely regulated pathways in one […]

Drug development in oncology is undergoing several changes brought about by precision medicine, which makes it appealing to move efficacy assessment to earlier-phase trials and questions the need for randomized trials. Indeed, some remarkably efficacious drugs have even been approved based on uncontrolled phase I or II trials. With very few exceptions, we challenge the […]

Introducing the new single-use separator, Alfa Laval CultureOne™ From greater flexibility to shorten the time to market, to increased assurance of patient safety, several factors have driven the growing transition to single-use processing in the biopharma industry. More manufacturers are seeking solutions that enable smaller batches and predictable, scalable production. Of course, this requires compact […]

Implementing and Validating Meso Scale Discovery – ECL Detection for Clinical Trials When implementing biomarker strategies for clinical trials, it is not only important to choose the right analysis platform but also have the assays validated and performed to meet regulatory submission requirements. Unilabs Serving Pharma group, in collaboration with Meso-Scale Discovery (MSD) will present […]

Discovering and characterizing novel drug candidates for preclinical development depends on innovative and reliable science. Charles River’s unique combination of integrated, multidisciplinary drug discovery expertise and unparalleled scope of capabilities in targets, platforms, and therapeutic areas allow us to deliver depth and breadth in science with data and insight you can trust to progress your […]

Keep up with transparency trends and leverage disclosure data for patient engagement and recruitment While the complexity and costs of clinical trial transparency regulations continue to increase, there are growing opportunities to leverage investments in disclosure compliance. Understanding the requirements and trends helps identify opportunities to reuse the disclosure data beyond submissions to regulatory authorities […]

The 7 most important things to update in your technical documentation and your QMS, and how they interact Do you want to understand which parts of the MDR that you as medical device manufacturer must have in place on May 26th and what you need to adjust in your technical documentation, when CE-marking a device […]