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Upcoming Events
Medicon Valley Alliance and Celerion would like to welcome you to a Good Morning Meeting. Abstract: Transitioning an experimental drug from preclinical animal models to the clinic is a critical milestone in bringing new medications to the market. First-in-Human (FiH) clinical studies have undergone a significant evolution, from a basic “feed-and-bleed” model in the 1970s, […]
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Medicon Valley Alliance and Syneos are pleased to invite you to a Good Morning Meeting on the 13th of March in Copenhagen focusing on: Navigating the current funding environment and other key challenges in drug development for 2024 and beyond. An overview of the recent dynamic environmental, economic, regulatory and payer developments which are creating […]
Read moreMedicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 23rd of January in Copenhagen focusing on: How to successfully address non-conformances raised by your Notified Body? Key learnings for the medical device manufacturers and to the Notified Body Opinion (NBOp) applicants Topics will include: Typical Notified […]
Read moreAll projects are different, but a number of parameters are consistent in addition to the guidelines/requirements from ICH, FDA, EMA. Selected characteristics of Small Molecule development projects will be discussed. Highlighting topics concerning: Management of risk and investment Optimization and adaptation of MedChem procedures towards manufacturing Sustainability Introduction of green(-er) chemistry Cost of waste management […]
Read moreJoin us to gain a greater understanding of the cancer patient journey as our speakers discuss early phase trial design along with optimal data collection and endpoint analysis. You’ll also hear about applying the right digital solutions to balance the needs of the patient, optimizing recruitment and retention and expediting key decision-making. This symposium unites […]
Read moreWe invite you to join us for a breakfast meeting centered around the crucial topic of Sponsor oversight for clinical trials, that are partly or fully outsourced to a Contract Research Organizations (CROs). This meeting aims to explore and elucidate the best practices and strategies for ensuring effective oversight in such Sponsor-CRO collaborations. As the […]
Read moreMedicon Valley Alliance and Genscript ProBio are pleased to invite you to a Good Morning Meeting on the 5th of October in Copenhagen focusing on accelerated ADC development via integrated antibody discovery platform. Key learning objectives: Brief overview of history and current trending of antibody-drug conjugates Tools and strategies for ADC naked antibody discovery & […]
Read moreMedicon Valley Alliance and IQVIA are pleased to invite you to a Good Morning Meeting on the 4th of October in Copenhagen focusing on how to create value for biotech companies through reducing risk, time to market and optimizing peak sales. Early stage biotech companies need to fill the evidence gaps at their stage of […]
Read moreThe transition from early (phase 1, expansion cohorts and single-arm phase 2) trials to later phases of clinical development poses several challenges. While many of these challenges are of strategic and financial natures, some usual methodological pitfalls can be addressed in a somewhat systematic fashion. In this presentation, we will explore these pitfalls and attempt […]
Read moreRecent years have seen a resurgence and rapid growth in the field of cell and gene therapies as therapeutic options to treat diverse clinical indications including neuromuscular diseases, ophthalmic disorders, haemophilia, cancers and much more. Designing and executing a complete bioanalytical strategy to support the preclinical and clinical development of cell and gene therapies can […]
Read moreIn recent years, pharmaceutical outsourcing of bioanalysis has grown tremendously. Simultaneously, bioanalytical programs have become more complex due to increasing regulatory demands. While a comprehensive understanding of the regulatory guidelines is required to develop a winning bioanalytical strategy, several other challenges, such as strategic timing, are common with outsourcing. Additionally, the regulatory environment of bioanalysis […]
Read moreMedicon Valley Alliance and Worldwide Clinical Trials are pleased to invite you to a Good Morning Meeting on the 24th of May in Copenhagen focusing on Rare but achievable – factors for successfully navigating rare oncology trials. Conducting clinical trials in rare oncology populations can have its challenges. This event – designed for C-level Executives, […]
Read moreContinued Process Verification (CPV) is replacing the traditional three PQ batch approach in the pharmaceutical industry. The FDA issued Warning Letters to seven companies in fiscal year 2021 for process validation issues, citing 21 CFR 211.100 (Subpart F- Production and Process Controls, written procedures; deviations). If you are currently in stage 3 and have not […]
Read moreMedicon Valley Alliance and pci Pharma Services are pleased to invite you to this Good Morning Meeting on the 11th of May in Copenhagen focusing on Preparing to Outsource – Selecting the Right Vendor. In today’s digital-first economy, globalization is the new norm, major organizations worldwide are now outsourcing and augmenting their staff more rapidly […]
Read moreTo succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor is to choose the right partners, that have the capacity to meet your […]
Read moreMedicon Valley Alliance and Metabolon are pleased to invite you to a Good Morning Meeting on the 20th of April in Copenhagen, focusing on advancing basic, clinical and applied research using state-of-the-art metabolomics data. Global biochemical profiling provides an informative assessment of the metabolome, which is reflective of a system’s active biology. Through metabolomics, opportunities […]
Read moreBiopharma companies are constantly looking for ways to accelerate time-to-market with minimal operational impact. Yet, when it comes to development, manufacturing and clinical supply of a biologic drug, they face challenges to increase productivity, reduce cost, mitigate risk, and optimize timelines to bring products to market faster. However, having the support of an integrated approach […]
Read moreAdvancing your drug or vaccine candidate from late-stage discovery into the clinic is one of the most critical steps in development. To maximize your chances of success, it is essential to de-risk your drug candidates as early as possible. This meeting will provide insights and solutions on how to de-risk your development and how to […]
Read moreMedicon Valley Alliance and Iqvia are pleased to invite you to a Good morning meeting on the 28th of November in Copenhagen focusing on maximizing your asset’s value using Real World Evidence. Regulators and payers are increasingly using real-world evidence (RWE) to support their decision-making. What does this mean for biotech companies and how can […]
Read moreIn this Good Morning Meeting, you will learn about successful strategies for recycling and future-proofing the valuable data assets generated in clinical studies. The most common destiny of the data from clinical studies is to be condensed into a one-off report and then archived. Meanwhile, lots of everyday activities throughout the organization can be accelerated […]
Read moreStrategies & Approaches to Optimize Your Clinical Immuno-Oncology Development Precision and Immuno-Oncology drug development is being optimized through well-defined preclinical and clinical strategies focused on safety, endpoints and biomarker targets. Evolutions in the regulatory framework, a deeper understanding of cancer and re-defining key endpoints for success in Immuno-Oncology and Precision Medicine are combining to de-risk […]
Read moreLearn about the benefits of phospholipids in pharmaceutical dosage forms and innovative drug delivery systems. Natural and synthetic phospholipids are ideal multi-purpose excipients with an unrivalled safety profile in state-of-the-art pharmaceutical dosage forms. In innovative drug delivery systems phospholipids – as enabling excipients – are crucial for ensuring the efficacy of therapeutics and vaccines. Within […]
Read moreThe New ICH M10 Guidelines A critical component of the regulatory decision regarding the efficacy and safety of therapeutic products is the bioanalytical concentration of therapeutic products in biological matrices. Therefore, it is imperative that the bioanalytical methods used are well characterized, validated, and documented to best support regulatory decisions. Explore the new ICH M10 […]
Read moreMore so than any other core function of the biopharma industry, clinical trials have been buffeted by the prevailing winds of the pandemic. From the turbulent waves of infection causing overstretched healthcare facilities, inaccessible sites and patient availability through to the relative plain sailing of mammoth Phase III vaccine trials, COVID-19 has permanently changed the […]
Read more– Overcoming challenges when moving from non-clinical to clinical Going from non-clinical to clinical is no easy step. That’s why we’ve gathered a few of our key experts from essential product development areas to talk about how to survive and minimize the early risks biotech companies face during the life cycle of product development. Join […]
Read more– Breaking through the current limitations Recombinant antibodies are highly specific detection probes in research, diagnostics, and have emerged over the last two decades as the fastest growing class of therapeutic proteins. Mammalian cell lines, especially the Chinese Hamster ovary (CHO) cell line, represent the most widely used expression systems for the production of these […]
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