Pharmacovigilance in the European Union : : Practical Implementation Across Member States.

• Author: Kaeding, Michael.
• TeilnehmendeR: Schmälter, Julia.; Klika, Christoph.
• Place / Publishing House: Wiesbaden : : Springer Fachmedien Wiesbaden GmbH,, 2017.; ©2017.
• Year of Publication: 2017
• Edition: 1st ed.
• Language: English
• Physical Description: 1 online resource (136 pages)

Table of Contents

• Intro
• Contents
• Abbreviations
• List of Tables, Figures and Boxes
• Preface
• 1 Introduction
• 1.1 Background and Terms of Reference
• 1.2 Methodology: Selection of Countries
• 1.3 Methodology: Research Strategy
• 1.4 Summary of Evidence
• 1.5 Implementation Assessment Structure
• References
• 2 Pharmacovigilance
• 2.1 Fundamentals of Pharmacovigilance
• 2.2 Importance of Pharmacovigilance for Biologicals
• References
• 3 The EU Pharmacovigilance System
• 3.1 EU Institutions and Pharmacovigilance Actors
• 3.2 Legislative Developments
• 3.3 The Pharmacovigilance Reform: Directive 2010/84/EU and Article 102
• References
• 4 Timely and Correct Transposition of Pharmacovigilance across Member States
• 4.1 Timely Transposition of Directive 2010/84/EU across Member States
• 4.2 Correct Transposition of Directive 2010/84/EU across Member States
• 4.2.1 Correct Transposition - Processes and Actors
• 4.2.2 Correct Transposition - Quality and Content
• References
• 5 Practical Implementation in Six Member States
• 5.1 ADR Reporting in the United Kingdom
• 5.1.1 The System
• 5.1.2 Perceived Challenges
• 5.1.3 Perceived Best Practices
• 5.2 ADR Reporting in Finland
• 5.2.1 The System
• 5.2.2 Perceived Challenges
• 5.2.3 Perceived Best Practices
• 5.3 ADR Reporting in Poland
• 5.3.1 The System
• 5.3.2 Perceived Challenges
• 5.3.3 Perceived Best Practices
• 5.4 ADR Reporting in France
• 5.4.1 The System
• 5.4.2 Perceived Challenges
• 5.4.3 Perceived Best Practices
• 5.5 ADR Reporting in Portugal
• 5.5.1 The System
• 5.5.2 Perceived Challenges
• 5.5.3 Perceived Best Practices
• 5.6 ADR Reporting in Germany
• 5.6.1 The System
• 5.6.2 Perceived Challenges
• 5.6.3 Perceived Best Practices
• References
• 6 Challenges and Best Practices in Perspective
• 6.1 Pharmacovigilance Systems
• 6.2 Major Challenges.
• 6.3 Comparison of Factors Contributing to Underreporting
• 6.3.1 Lack of Awareness
• 6.3.2 Complexity of ADR Reporting
• 6.3.3 Lack of Cooperation
• 6.3.4 Interconnectivity Problems
• References
• 7 Conclusions and Recommendations
• 7.1 Specific Recommendations in Relation to Article 102
• 7.2 General Recommendations: National Healthcare Systems and Policy Options for Pharmacovigilance
• References.