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Patient Involvement In The Development Regulation And Safe Use Of Medicines

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Patient Involvement In The Development Regulation And Safe Use Of Medicines

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Author : Council for International Organizations of Medical Sciences (CIOMS)
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2022-09-05

Patient Involvement In The Development Regulation And Safe Use Of Medicines written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-09-05 with Medical categories.

This report describes the importance of systematically involving patients throughout a medicine’s life – from its early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organizational and national needs. The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. It also incorporates views gathered from an open meeting in Switzerland and a workshop in Uganda, which both brought together members of the public, patient organization representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalized following a public consultation. CIOMS is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and pharmacovigilance. https://doi.org/10.56759/iiew8982

Cobert S Manual Of Drug Safety And Pharmacovigilance Fourth Edition

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Author :
language : en
Publisher: World Scientific
Release Date : 2024

Cobert S Manual Of Drug Safety And Pharmacovigilance Fourth Edition written by and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024 with Drug monitoring categories.

This work is an updated how-to manual of guiding principles and concepts for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety and pharmacovigilance, and provides essential information on drug safety and regulations in the United States, European Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. This text teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies -- both in the United States and around the world -- and provides critical information about what to do when confronted with a drug safety problem --

Essentials Of Translational Pediatric Drug Development

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Author : Elke Gasthuys
language : en
Publisher: Elsevier
Release Date : 2024-07-23

Essentials Of Translational Pediatric Drug Development written by Elke Gasthuys and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-23 with Medical categories.

Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development

Real World Data And Real World Evidence In Regulatory Decision Making

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Author : Council for International Organizations of Medical Sciences
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2024-05-29

Real World Data And Real World Evidence In Regulatory Decision Making written by Council for International Organizations of Medical Sciences and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-29 with Science categories.

In recent years, many medicines regulatory agencies have expressed increased willingness to consider real-world evidence (RWE), that derives from the review and/or analysis of real-world data (RWD), to support claims of efficacy or effectiveness as well as of safety. This increased willingness is changing the regulatory environment in which RWE is generated and used. This consensus report aims to describe the potential use of RWE for decision making; RWD and data sources; key scientific considerations in the generation of RWE; and ethical and governance issues in using RWD. The intended audience for this report includes medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals. This report was developed to inform discussions about the use of RWD and RWE for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). This report reflects the opinions of the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII on Real-world data and real-world evidence in regulatory decision making, and it was finalised after considering comments received during a public consultation.

Where To From Here Advancing Patient And Public Involvement In Health Technology Assessment Hta Following The Covid 19 Pandemic

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Author : Janet L. Wale
language : en
Publisher: Frontiers Media SA
Release Date : 2023-05-09

Where To From Here Advancing Patient And Public Involvement In Health Technology Assessment Hta Following The Covid 19 Pandemic written by Janet L. Wale and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-09 with Medical categories.

Ethical Innovation For Global Health

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Author : Chieko Kurihara
language : en
Publisher: Springer Nature
Release Date : 2023-11-14

Ethical Innovation For Global Health written by Chieko Kurihara and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-14 with Medical categories.

This volume captures the recent changes and evolution in ethics in research involving humans and provides future directions to achieve alternative drug development strategies for equitable global health. It presents ethical considerations in current day clinical trials and new trends of ethics in research. It also describes the historical context, illustrates the process in alternative paradigms to achieve democracy after World War II, how the framework of ethics in research was established in different regions, and policies implemented to protect research participants from the exploitation of new drug development. The book is organized into three themed parts: relevant constructions from Brazil, South Africa, Taiwan, South Korea, and Japan; historical and international perspectives of principles of ethics in research; and alternative frameworks of clinical development and innovation. Ethical Innovation for Global Health: Pandemic, Democracy and Ethics in Research is an informative resource for academic researchers, the global pharmaceutical industry, regulators, civil society and other role players involved in global health. It is contributed to by leaders in global policy development in research ethics, and experts in drug development activities with its trajectory being global health. The COVID-19 pandemic, as a global disaster, necessitated not only socio-economic but also cultural transformation. While effective vaccines were developed under a successful new methodology, there remains inequity of distribution of these vaccines globally. The book re-engages with the notion of the primacy of distributing results of scientific innovation to those who most require the benefits.

Principles And Practice Of Pharmacovigilance And Drug Safety

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Author : Jimmy Jose
language : en
Publisher: Springer Nature
Release Date : 2024-08-05

Principles And Practice Of Pharmacovigilance And Drug Safety written by Jimmy Jose and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-08-05 with Medical categories.

The science of drug safety and pharmacovigilance has rapidly evolved in the 21st century. The knowledge and principles it contains are of increasing importance in clinical and practice settings. The aim of this book is to deal with the gap in knowledge about pharmacovigilance and drug safety, including the application of pharmacovigilance knowledge to individual patient cases in clinical practice. A holistic approach is taken with each chapter written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Chapters offer key material on adverse drug reactions, medication errors, prescribing safety, pharmacovigilance as well as data sources used in drug safety and pharmacovigilance. Each chapter is structured as a self-contained learning resource, with learning objectives, and worked cases. The book is suitable for undergraduate healthcare professions, postgraduate students, researchers, clinical practitioners – including those with prescribing responsibilities. It will also be useful for professionals moving from a clinical practice role to a specialist pharmacovigilance role. For those already in a pharmacovigilance role, the book offers insight into the theory and practice of drug safety and pharmacovigilance in clinical settings.

Benefit Risk Balance For Medicinal Products

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Author :
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2025-05-27

Benefit Risk Balance For Medicinal Products written by and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-27 with Medical categories.

This report provides insights into the methods used to evaluate the benefit-risk (BR) balance of a medicinal product. A favourable BR profile must be established for all medicinal products prior to marketing. This balance must be reassessed periodically in the post-marketing setting when new information regarding the benefits and risks, or the landscape of their application, becomes available. This report builds on the foundations of the CIOMS Working Group IV report published in 1998, and entitled: BenefitRisk Balance for Marketed Drugs: Evaluating Safety Signals; and expands to BR management throughout a product’s lifecycle using structured approaches and updated methodologies. This report reflects the consensus opinion of the CIOMS Working Group XII members, including experts in BR assessment drawn from academia, industry, and regulatory organisations. It was finalised after considering comments received during a public consultation. The report is intended for medicinal product developers, regulatory authorities, and key stakeholders including academic and government researchers, healthcare professionals, and patients/consumers – all those interested in how the balance between the benefits and risks associated with a medicinal product is established and managed. https://doi.org/10.56759/gwfz1791

International Guidelines On Good Governance Practice For Research Institutions

International Guidelines On Good Governance Practice For Research Institutions written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-27 with Science categories.

Scientific research is essential to improve the health and well-being of people around the world, and to respond to health emergencies. Since the 1960s many ethical and professional guidance documents have been adopted, typically focusing on individual researchers’ responsibilities to conduct ethical, good quality scientific studies. But to what extent are researchers given the necessary resources for this purpose at their institutions? These CIOMS guidelines review the existing standards and best practices in the field, and offer research institutions detailed and specific guidance on how to implement them.

Cioms Cumulative Glossary With A Focus On Pharmacovigilance

Cioms Cumulative Glossary With A Focus On Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-31 with Science categories.

person My Account Log Out PUBLICATIONS Home Products Recently published CIOMS Cumulative Glossary with a Focus on Pharmacovigilance - 75th Anniversary Edition CIOMS Cumulative Glossary with a Focus on Pharmacovigilance – 75th Anniversary Edition Reflecting the work of CIOMS over the past decades, this glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. It includes links to the reports and, where applicable, provides references to the sources from which the definitions were adopted or modified. The 75th Anniversary Edition covers the terms included in fifteen different CIOMS reports published between 1992 and 2024. It does not cover CIOMS r Read more... In Stock isbn: 978-929036108-4 Year of publication: 2024 Number of pages: 143 SKU: 67000 https://doi.org/10.56759/ocef1297 Previous versions: CIOMS Cumulative glossaries (archived) Quick links: Book Description Download free PDF book Free Hardcopy, postage will be added 0 00 CHF Amount: CIOMS Cumulative Glossary with a Focus on Pharmacovigilance - 75th Anniversary Edition quantity Add to cart Reflecting the work of CIOMS over the past decades, this glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. It includes links to the reports and, where applicable, provides references to the sources from which the definitions were adopted or modified. The 75th Anniversary Edition covers the terms included in fifteen different CIOMS reports published between 1992 and 2024. It does not cover CIOMS reports on the subjects search ethics, pharmacogenetics, clinical pharmacology, publications on the development and use of standardised MedDRA® queries (SMQs), or publications resulting from CIOMS Roundtable Discussions (1967–1997).

Patient Involvement In The Development Regulation And Safe Use Of Medicines

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