The briefing presents a proposal for the ratification of the 2003 UNESCO Convention on Safeguarding Intangible Cultural Heritage (ICH). The Convention aims to safeguard, preserve, and promote ICH, which includes practices, knowledge, skills, and cultural spaces passed down through generations. It em

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This PowerPoint presentation by UNESCO explores the connection between Intangible Cultural Heritage (ICH) and Disaster Risk Reduction (DRR). It covers key concepts like disasters, risks, vulnerabilities, and resilience, emphasizing the importance of safeguarding and mobilizing ICH in the face of dis

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The regulatory implementation of the Estimand Framework in the U.S. context has evolved over time, addressing issues related to missing data in clinical trials. Starting from the pre-history of missing data recognition to the development of the ICH E9(R1) framework, the focus has been on aligning pl

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The concept of estimands in oncology clinical trials plays a crucial role in defining treatment effects and analyzing overall survival outcomes. This framework aims to enhance transparency, align trial objectives, and strengthen interdisciplinary dialogues. Introduced by the ICH E9(R1) guideline in

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This content discusses the importance of creating Corrective Action and Preventive Action (CAPA) plans for protocol deviations in clinical trials. It covers the components of a CAPA, best practices for creating CAPAs for different deviation types, and regulatory compliance requirements according to

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This presentation by Derita Bran, BSN, RN, CCRC, focuses on the documentation required for quality clinical trials, emphasizing Essential Documents outlined in the ICH GCP E6 (R2) guidance. It covers the purpose, definition, and importance of these documents in ensuring subject rights protection, da

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Understand the importance of handling protocol deviations in clinical trials to ensure patient safety, data integrity, and compliance with regulatory requirements. Explore SOPs, electronic systems, and best practices for managing deviations effectively. Learn about GCP requirements, DMC usefulness,

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Investigational products play a crucial role in clinical trials, encompassing drugs, devices, biologics, and more. The FDA defines investigational new drugs as substances seeking approval, even if previously in use, with potential changes. Similarly, investigational devices are those under investiga

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Explore the fundamentals of informed consent in research, including ICH G6 (R2) guidance, study resources, webinars, and contact information for further inquiries at dbran@uthsc.edu and mlynn@uthsc.edu.

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The International Conference on Harmonization (ICH) aims to harmonize technical requirements for pharmaceutical registrations globally. Through the Common Technical Document (CTD) framework, it promotes efficiency, cost-effectiveness, and high quality in medicine development. The ICH provides recomm

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Canine Infectious Hepatitis (ICH), also known as Rubarth's Disease, is caused by Canine Adenovirus-1 (CAdV-1), affecting dogs of all ages. The virus primarily targets hepatocytes, leading to acute hepatitis, as well as respiratory and ocular issues. Transmission occurs through contact with infected

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Lack of clarity in trial objectives can lead to confusion among developers, decision-makers, patients, and prescribers. Estimands at ICH, presented by Rob Hemmings, address the need to focus on WHAT to estimate rather than just HOW. Patients differ in response to treatment, and multiple treatment ef

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Learn how to apply a community-based approach to inventorying and safeguarding intangible cultural heritage within the context of disasters. This presentation offers frameworks, tools, and exercises to integrate disaster awareness into ICH inventorying and safeguarding practices, emphasizing the imp

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Explore the Clinical Trials Transformation Initiative's efforts in updating ICH E6 guidelines to improve global clinical trials. Learn about CTTI's findings, insights from stakeholders, and discussions on the necessary updates for ICH E6. Engage with industry experts and regulatory authorities to un

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