000			03960nam a22004333i 4500
001			EBC5590983
003			MiAaPQ
005			20240322153602.0
007			cr cnu||||||||
008			231128s2017 xx o ||||0 eng d
020			_a9783658172763 _q(electronic bk.)
020			_z9783658172756
035			_a(MiAaPQ)EBC5590983
035			_a(Au-PeEL)EBL5590983
035			_a(OCoLC)980869903
040			_aMiAaPQ _beng _erda _epn _cMiAaPQ _dMiAaPQ
050		4	_aJF20-1177
100	1		_aKaeding, Michael.
245	1	0	_aPharmacovigilance in the European Union : _bPractical Implementation Across Member States.
250			_a1st ed.
264		1	_aWiesbaden : _bSpringer Fachmedien Wiesbaden GmbH, _c2017.
264		4	_c�2017.
300			_a1 online resource (136 pages)
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
505	0		_aIntro -- 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.
505	8		_a6.3 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			_aDescription based on publisher supplied metadata and other sources.
590			_aElectronic 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	_aElectronic books.
700	1		_aSchm�alter, Julia.
700	1		_aKlika, Christoph.
776	0	8	_iPrint version: _aKaeding, Michael _tPharmacovigilance in the European Union _dWiesbaden : Springer Fachmedien Wiesbaden GmbH,c2017 _z9783658172756
797	2		_aProQuest (Firm)
856	4	0	_uhttps://ebookcentral.proquest.com/lib/kliuc-ebooks/detail.action?docID=5590983 _zClick to View
942			_2lcc _cEBK
999			_c332706 _d332706