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Download or read book GLOBAL PHARMACEUTICAL AND BIOLOGICS REGULATORY STRATEGY. written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Gloria Hall
Publisher:
Published: 2020-03-06
Total Pages:
ISBN-13: 9781947493414
DOWNLOAD EBOOKDownload or read book Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition written by Gloria Hall and published by . This book was released on 2020-03-06 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: John Geigert
Publisher: Springer Science & Business Media
Published: 2014-07-08
Total Pages: 362
ISBN-13: 1461469163
DOWNLOAD EBOOKThis book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Author: Petra Heyen
Publisher: GRIN Verlag
Published: 2011-03-14
Total Pages: 89
ISBN-13: 3640862570
DOWNLOAD EBOOKMaster's Thesis from the year 2004 in the subject Health - Miscellaneous, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultät), language: English, abstract: The Regulatory Affairs (RA) department is a key discipline in the global network of drug development. During drug development, regulatory strategy is one crucial success factor for the approval of the development candidate. Also, regulatory strategy can optimise labelling in the key countries in order to maximise the market success. No submission and approval would be possible without the appropriate dossier composition and compilation. Without adherence to the respective guidance documents and scientific advice from Health Authorities to design the optimal clinical development plan, optimal labelling would not be feasible. These two examples show some characteristics of the regulatory strategy: it is highly interactive with other disciplines and it is heavily based on a thorough intelligence work which enables the RA Manager to know the "rules of the game" and to develop the optimal regulatory strategy for the current development candidate. The major cornerstone for developing a regulatory strategy is regulatory intelligence. This document focuses on regulatory intelligence. The regulatory contributions to the global drug development from early research to submission are described. Strategies for generic drugs as well as detailed strategies for life-cycle management are excluded. Major components of regulatory intelligence are: - Competitor Information - Information on Regulatory Environment - Information on Legal Requirements Competitor analysis is an essential aspect of the intelligence work. Sources of competitive information as well as relevant items of competitive information are described. Sources of information about the regulatory environment and sources of information about the legal regulatory environment are described and their tremendous impact on setting up and modify
Download or read book Regulatory Intelligence as the Basis for Regulatory Strategy and Global Drug Development written by Petra Heyen and published by GRIN Verlag. This book was released on 2011-03-14 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: Master's Thesis from the year 2004 in the subject Health - Miscellaneous, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultät), language: English, abstract: The Regulatory Affairs (RA) department is a key discipline in the global network of drug development. During drug development, regulatory strategy is one crucial success factor for the approval of the development candidate. Also, regulatory strategy can optimise labelling in the key countries in order to maximise the market success. No submission and approval would be possible without the appropriate dossier composition and compilation. Without adherence to the respective guidance documents and scientific advice from Health Authorities to design the optimal clinical development plan, optimal labelling would not be feasible. These two examples show some characteristics of the regulatory strategy: it is highly interactive with other disciplines and it is heavily based on a thorough intelligence work which enables the RA Manager to know the "rules of the game" and to develop the optimal regulatory strategy for the current development candidate. The major cornerstone for developing a regulatory strategy is regulatory intelligence. This document focuses on regulatory intelligence. The regulatory contributions to the global drug development from early research to submission are described. Strategies for generic drugs as well as detailed strategies for life-cycle management are excluded. Major components of regulatory intelligence are: - Competitor Information - Information on Regulatory Environment - Information on Legal Requirements Competitor analysis is an essential aspect of the intelligence work. Sources of competitive information as well as relevant items of competitive information are described. Sources of information about the regulatory environment and sources of information about the legal regulatory environment are described and their tremendous impact on setting up and modify
Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802864
DOWNLOAD EBOOKCompilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Download or read book Global Pharmaceutical and Biologics Regulation written by and published by . This book was released on 2014-05-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Author: Hiten J. Gutka
Publisher: Springer
Published: 2018-12-13
Total Pages: 709
ISBN-13: 3319996800
DOWNLOAD EBOOKThis book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Download or read book Biosimilars written by Hiten J. Gutka and published by Springer. This book was released on 2018-12-13 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Author: John Geigert
Publisher: Springer
Published: 2019-05-08
Total Pages: 426
ISBN-13: 3030137546
DOWNLOAD EBOOKBiopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802888
DOWNLOAD EBOOKCompilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Download or read book Global Pharmaceutical and Biologics Regulation written by and published by . This book was released on 2014-05-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2020-04-25
Total Pages: 169
ISBN-13: 0309498635
DOWNLOAD EBOOKGlobalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
