Novedades

In questo episodio parliamo dell’importanza degli smalti da macinazione nella produzione di piastrelle ceramiche.La fase di smaltatura richiede sospensioni con proprietà reologiche precise per un’applicazione uniforme e un risultato finale di qualità.Ma cosa succede se maciniamo uno smalto solo con acqua?Avremo problemi di coesione, sedimentazione veloce e mancanza di livellamento, compromettendo l’intero processo. Gli additivi chimici – fluidificanti e leganti – sono fondamentali già durante la macinazione, e vanno scelti in base al tipo di applicazione: airless ad alta o bassa ...

This episode introduces emerging trends and innovative methodologies that promise to reshape drug discovery. The conversation dives into forward-looking ideas, paradigm shifts, and cutting-edge research highlighted in OPR&D studies. Al's role in finding new uses for drugs that we already have is discussed, especially how it can be efficient in the underfunded areas of neglected tropical diseases.The episode looks at how Pharma research generates vast amounts of data and the use of Al to manage it, pulling out useful insights. It details the use of Al and machine learning to handle messy data ...

In this episode, Ecolink sits down with Anna Sampson, Executive Director of We Are Neutral, to talk through our journey toward carbon neutrality — what it really takes, what we've learned, and how your organization can do it too. We also break down the biggest myths around carbon offsets and share how to make a real, measurable climate impact without the greenwashing.Learn how to go carbon neutral the right way — and why it matters now more than ever.

Take a deep dive into the world of light curing units with Dr. Rolando Nuñez in Episode 27 of the Bonding and Beer dental podcast. Is your light curing unit up to par? Does your curing unit have a high enough milliwatt output? Get your curing light questions answered and learn more about beam profile, collimation, wavelength, and intensity.Visit our website! It's the perfect place to submit questions, suggestions, and learn more about the show: https://info.bisco.com/bonding-and-beer-landing Follow us on Instagram to stay updated with everything Bonding and Beer!Check out the video version of...

In this episode of our Sustainability in Action podcast series, we spotlight the Performance Products team—winners of the Huntsman Corporation's 2024 CEO Award for Manufacturing Excellence—for their innovative project, “Turning Straw Into Gold: Recycling Ethyleneamine (EA) Lights" Responding to evolving market dynamics, the team reengineered operations at two Ethyleneamines (EA) plants to reduce production of lower-value products and increase output of more profitable, in-demand materials. By creatively repurposing existing equipment and optimizing processes, they achieved significant ...

In our next episode, we’re joined by Jason Cole, a Senior Research Fellow at the Cambridge Crystallographic Data Center (CCDC). He shares his fascinating journey, starting from his childhood in Italy, where his love for science blossomed, all the way to his impressive career in computational chemistry and crystallography. We chat about what CCDC does in terms of gathering and sharing crystallographic data, the ups and downs of software development in this field, and why it’s so crucial to validate docking software. Jason also highlights the importance of data standards, the philanthropic ...

This episode offers listeners a chance to become more knowledgeable on how they can audit preparedness, by using internal audits. We will discuss corrective action processes and share strategies for ensuring ongoing quality improvement.Our goal is to help empower these organization with information on how to maintain compliance and risk management. The ultimate intention is to show how this can ensure that clinical operations stay strong, aligned with the most current cGCP regulations, transparent, and robust.This episode will use FDA regulations, ICH guidelines, and GMP, quality, and ...

This episode defines current Good Clinical Practices (cGCPs) and explores their pivotal role in safeguarding trial participants and ensuring the integrity of data. It delves into the ethical considerations inherent in clinical research, emphasizing the significance of informed consent as a cornerstone of ethical practice. The discussion also highlights the critical importance of meticulous protocol design in establishing a solid foundation for robust clinical research. Furthermore, the episode navigates through the key concepts and aims to simplify the understanding of CGCPs for a broader ...

This episode explores the critical processes of risk management and quality assurance within the clinical research environment. It will focus on GMPs, premises, processes, products, and procedures, and how they impact quality. Beyond that, the episode discusses the physical space of equipment and how that impacts the final product.The episode details effective strategies for monitoring compliance, managing deviations from protocols, and implementing CAPA (Corrective and Preventative Action) measures. These measures play a pivotal role in upholding study integrity, enhancing data reliability, ...

This episode dives into the complex world of U.S. regulations for clinical trials. Examine the detailed provisions within U.S. regulations for clinical trials as we explain how FDA guidance documents, relevant sections of 21 CFR, and associated Q&A documents shape current clinical practices. We will also break down enforcement strategies, such as inspection protocols, providing practical examples of regulatory interpretations to ensure adherence to cGCP requirements.We'll discuss how the Bioresearch Monitoring Program (BiMo) oversees clinical trials through inspections and audits. This ...

This episode serves as a refreshing dive into the key aspects of documentation in clinical trials, making it much more than a dry overview. We'll journey through aspects of informed consent procedures, adverse event reporting, and the very best record-keeping practices.Ultimately, the intention of this exploration is to provide reliable guidance on how to maintain accurate audit trails. By the end, it will be much more clear that all documentation needs to not only meet regulatory standards but also should support continuous quality improvement.Throughout the episode, we'll illuminate the ...

This is a dive into ICH guidelines, specifically E6(R2), which is a corner stone of current Good Clinical Practices, that shapes cGCP worldwide. We discuss the reasoning behind harmonization efforts and the way these standards are influencing national regulations.This also discusses that ICH Guidelines, particularly the E6 R2 guideline, is about ensuring that clinical trials are conducted ethically. There is a focus on patient safety throughout every step. Practical implications for multinational trials and compliance strategies will be covered throughout this podcast episode.

Delve into the expansive regulatory framework that governs clinical trials. Discover the critical roles played by key agencies such as the FDA, EMA, and WHO, and understand how ICH guidelines, like ICH E6(R2), fit into the overall picture. We'll also explore the history and evolution of these regulations, tracing their origins and how they've adapted over time. This episode will highlight the interconnectedness of these regulations, revealing how they form a global system dedicated to ethical conduct, participant safety, and the generation of high-quality data in clinical research.Journey ...

Details and explains the enforcement mechanisms that regulatory agencies employ to make sure cGCP compliance. Also explained is the role that audit procedures, risk-based inspections, and corrective actions have.This includes the ways that all of the previous measures drive continuous improvement and to safe guard participant safety in clinical research. Discussions on good documentation practices will take place, the types of audits are performed, and the role they take in maintaining GCP compliance. Validation practices tie into many aspects of CGMP, and will be discussed in full detail.

his episode recaps the essential principles of current Good Clinical Practice (cGCP) and provides a comprehensive overview of the regulatory framework governing clinical trials. We emphasize the key ethical, legal, and operational standards that underpin this framework. A core focus is on how these concepts work to protect participants involved in research and simultaneously ensure the delivery of high-quality research outcomes. Ultimately, our mission is to provide listeners with a clear and jargon-free understanding of these important concepts.The discussion delves into key ethical ...

This episode explores the fundamental components of clinical trial protocols, the roles assumed by investigators in these trials, and the essential nature of thorough documentation. It will focus on the importance of having well-defined objectives and how researchers need to be on the same page about how to collect data and how to analyze it. From there, the need for safety monitoring and appropriate protocols is examined.It also discusses how meticulously designed protocols, comprehensive training programs, and robust record-keeping practices ensure compliance with both ethical and regulatory...

Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences.Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This podcast explores how they navigate differing regulations and how it affects the creation of ...

This episode discusses the move toward sustainable practices and green chemistry in drug development and manufacturing. Dialogue on environmental initiatives, innovative chemistry approaches, and documented case studies is provided. There is much discussion on pollution, waste, resource depletion, and economics.The episode also explores the 12 core principles and some of the most important, including waste prevention and atom economy. The conversation goes into detail about examples, like safer solvents and how to use them. There is much discussion about specific documents, such as the 20201 D...

This episode explores the fundamental principles of data integrity and its importance in ensuring trial trustworthiness. It delves into the critical role of informed consent, which is the ethics and heart of clinical research, emphasizing the need for willingly and knowingly involved people in these trials. Finally, it explores the best practices in recordkeeping for clinical trials.Finally, the use of key terms like audit trails and source data verification, is discussed, and the practical processes that support reliable, ethical, and compliant clinical research operations. This episode also ...