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  1. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
    Autor*in: Wood, Linda Fossati
    Erschienen: 2009
    Verlag:  Birkhäuser Basel, Basel

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors... mehr

    Standort:
    Universität Potsdam, Universitätsbibliothek
    Fernleihe:
    uneingeschränkte Fernleihe, Kopie und Ausleihe

     

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed, how to start the process using writer’s tools like templates and style guides, how to write individual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing, covering specific document types, as well as submissions to all major regions of the world. It is written by two regulatory writers with more than 20 years experience each.

     
    Export in Literaturverwaltung   RIS-Format
      BibTeX-Format
    Hinweise zum Inhalt
    Volltext (lizenzpflichtig)
    Quelle: Verbundkataloge
    Sprache: Englisch
    Medientyp: Ebook
    Format: Online
    ISBN: 9783764383626
    Weitere Identifier:
    RVK Klassifikation: AN 98200 ; XI 1100
    Schlagworte: Biotechnology; Pharmacy; Toxicology; Medicine; Drug Approval; Documentation; Drug Industry; Writing
    Umfang: Online-Ressource, v.: digital
    Bemerkung(en):

    Includes bibliographical references and index

    Electronic reproduction; Available via World Wide Web

    Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America
  2. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
    Erschienen: 2009
    Verlag:  Birkhäuser Basel, Basel

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors... mehr

    Standort:
    Universität Potsdam, Universitätsbibliothek
    Fernleihe:
    uneingeschränkte Fernleihe, Kopie und Ausleihe

     

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed, how to start the process using writer’s tools like templates and style guides, how to write individual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing, covering specific document types, as well as submissions to all major regions of the world. It is written by two regulatory writers with more than 20 years experience each.

     
    Export in Literaturverwaltung   RIS-Format
      BibTeX-Format
    Quelle: Verbundkataloge
    Sprache: Englisch
    Medientyp: Ebook
    Format: Online
    ISBN: 9783764383626
    Weitere Identifier:
    RVK Klassifikation: XI 1100 ; AN 98200
    Schriftenreihe: Array
    Schlagworte: Medicine; Toxicology; Biotechnology; Pharmacy; Biomedicine; Biotechnology; Pharmacy; Toxicology; Medicine; Drug Approval; Documentation; Drug Industry; Writing
    Umfang: Online-Ressource (digital)
    Bemerkung(en):

    Includes bibliographical references and index

    Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America
  3. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
    Autor*in: Wood, Linda Fossati
    Erschienen: 2009
    Verlag:  Birkhäuser Basel, Basel

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors... mehr

    Standort:
    Universitätsbibliothek Greifswald
    Fernleihe:
    keine Fernleihe

    Standort:
    Technische Universität Hamburg, Universitätsbibliothek
    Fernleihe:
    keine Fernleihe

    Standort:
    Otto-von-Guericke-Universität, Universitätsbibliothek
    Signatur:
    eBook Springer
    Fernleihe:
    keine Fernleihe

    Standort:
    Otto-von-Guericke-Universität, Universitätsbibliothek, Medizinische Zentralbibliothek
    Signatur:
    eBook Springer
    Fernleihe:
    keine Fernleihe

    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe
    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe
    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe

    Standort:
    Universität Potsdam, Universitätsbibliothek
    Fernleihe:
    keine Fernleihe

     

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed, how to start the process using writer’s tools like templates and style guides, how to write individual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing, covering specific document types, as well as submissions to all major regions of the world. It is written by two regulatory writers with more than 20 years experience each.

     
    Export in Literaturverwaltung   RIS-Format
      BibTeX-Format
    Hinweise zum Inhalt
    Volltext (lizenzpflichtig)
    Quelle: Verbundkataloge
    Sprache: Englisch
    Medientyp: Ebook
    Format: Online
    ISBN: 9783764383626
    Weitere Identifier:
    RVK Klassifikation: AN 98200 ; XI 1100
    Schlagworte: Biotechnology; Pharmacy; Toxicology; Medicine; Drug Approval; Documentation; Drug Industry; Writing
    Umfang: Online-Ressource, v.: digital
    Bemerkung(en):

    Includes bibliographical references and index

    Electronic reproduction; Available via World Wide Web

    Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America
  4. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
    Erschienen: 2009
    Verlag:  Birkhäuser Basel, Basel

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors... mehr

    Standort:
    Universitätsbibliothek Greifswald
    Fernleihe:
    keine Fernleihe

    Standort:
    Technische Universität Hamburg, Universitätsbibliothek
    Fernleihe:
    keine Fernleihe

    Standort:
    Otto-von-Guericke-Universität, Universitätsbibliothek
    Signatur:
    eBook Springer
    Fernleihe:
    keine Fernleihe

    Standort:
    Otto-von-Guericke-Universität, Universitätsbibliothek, Medizinische Zentralbibliothek
    Signatur:
    eBook Springer
    Fernleihe:
    keine Fernleihe

    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe
    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe
    Standort:
    Bibliotheks-und Informationssystem der Carl von Ossietzky Universität Oldenburg (BIS)
    Fernleihe:
    keine Fernleihe

    Standort:
    Universität Potsdam, Universitätsbibliothek
    Fernleihe:
    keine Fernleihe

     

    The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed, how to start the process using writer’s tools like templates and style guides, how to write individual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing, covering specific document types, as well as submissions to all major regions of the world. It is written by two regulatory writers with more than 20 years experience each.

     
    Export in Literaturverwaltung   RIS-Format
      BibTeX-Format
    Quelle: Verbundkataloge
    Sprache: Englisch
    Medientyp: Ebook
    Format: Online
    ISBN: 9783764383626
    Weitere Identifier:
    RVK Klassifikation: XI 1100 ; AN 98200
    Schriftenreihe: Array
    Schlagworte: Medicine; Toxicology; Biotechnology; Pharmacy; Biomedicine; Biotechnology; Pharmacy; Toxicology; Medicine; Drug Approval; Documentation; Drug Industry; Writing
    Umfang: Online-Ressource (digital)
    Bemerkung(en):

    Includes bibliographical references and index

    Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America