| 000 -LEADER |
|---|
| fixed length control field |
03960nam a22004333i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
EBC5590983 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
MiAaPQ |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20240322153602.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
|---|
| fixed length control field |
cr cnu|||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
231128s2017 xx o ||||0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9783658172763 |
| Qualifying information |
(electronic bk.) |
|
|---|
| Cancelled/invalid ISBN |
9783658172756 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(MiAaPQ)EBC5590983 |
|
|---|
| System control number |
(Au-PeEL)EBL5590983 |
|
|---|
| System control number |
(OCoLC)980869903 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
MiAaPQ |
| Language of cataloging |
eng |
| Description conventions |
rda |
| -- |
pn |
| Transcribing agency |
MiAaPQ |
| Modifying agency |
MiAaPQ |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
JF20-1177 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Kaeding, Michael. |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Pharmacovigilance in the European Union : |
| Remainder of title |
Practical Implementation Across Member States. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
1st ed. |
| 264 #1 - |
|---|
| -- |
Wiesbaden : |
| -- |
Springer Fachmedien Wiesbaden GmbH, |
| -- |
2017. |
|
|---|
| -- |
�2017. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource (136 pages) |
| 336 ## - |
|---|
| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
|---|
| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
|---|
| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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. |
|
|---|
| Formatted contents note |
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. |
| 588 ## - |
|---|
| -- |
Description based on publisher supplied metadata and other sources. |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2023. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. |
| 655 #4 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Schm�alter, Julia. |
|
|---|
| Personal name |
Klika, Christoph. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Print version: |
| Main entry heading |
Kaeding, Michael |
| Title |
Pharmacovigilance in the European Union |
| Place, publisher, and date of publication |
Wiesbaden : Springer Fachmedien Wiesbaden GmbH,c2017 |
| International Standard Book Number |
9783658172756 |
| 797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN) |
|---|
| Corporate name or jurisdiction name as entry element |
ProQuest (Firm) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
https://ebookcentral.proquest.com/lib/kliuc-ebooks/detail.action?docID=5590983 |
| Public note |
Click to View |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
E-book |
