Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

Jürgen Beckmann, Ulrich Hagemann, Priya Bahri, Andrew Bate, Ian Boyd, Gerald Pan, Brian Edwards, I. Edwards, Kenneth Hartigan-Go, Marie Lindquist, John MCEWEN, Yola Moride, Sten Olsson, Shanthi Pal, Rachida Soulaymani-Bencheikh, Marco Tuccori, Claudia Vaca, Ian Wong

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognized during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in different regions of the world. Also, theoretical knowledge needs supplementing with experience and practical skills
Original languageEnglish
Pages (from-to)743-759
Number of pages17
JournalDrug Safety
Volume37
Issue number10
DOIs
Publication statusPublished - 2014

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Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Curriculum
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Medicine
Teaching
Pharmacoepidemiology
Pharmaceutical Technology
Pharmaceutical Preparations
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Clinical Medicine
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Jurisprudence
Internet
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Beckmann, J., Hagemann, U., Bahri, P., Bate, A., Boyd, I., Pan, G., ... Wong, I. (2014). Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum. Drug Safety, 37(10), 743-759. https://doi.org/10.1007/s40264-014-0216-1
Beckmann, Jürgen ; Hagemann, Ulrich ; Bahri, Priya ; Bate, Andrew ; Boyd, Ian ; Pan, Gerald ; Edwards, Brian ; Edwards, I. ; Hartigan-Go, Kenneth ; Lindquist, Marie ; MCEWEN, John ; Moride, Yola ; Olsson, Sten ; Pal, Shanthi ; Soulaymani-Bencheikh, Rachida ; Tuccori, Marco ; Vaca, Claudia ; Wong, Ian. / Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum. In: Drug Safety. 2014 ; Vol. 37, No. 10. pp. 743-759.
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Beckmann, J, Hagemann, U, Bahri, P, Bate, A, Boyd, I, Pan, G, Edwards, B, Edwards, I, Hartigan-Go, K, Lindquist, M, MCEWEN, J, Moride, Y, Olsson, S, Pal, S, Soulaymani-Bencheikh, R, Tuccori, M, Vaca, C & Wong, I 2014, 'Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum', Drug Safety, vol. 37, no. 10, pp. 743-759. https://doi.org/10.1007/s40264-014-0216-1

Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum. / Beckmann, Jürgen; Hagemann, Ulrich; Bahri, Priya; Bate, Andrew; Boyd, Ian; Pan, Gerald; Edwards, Brian; Edwards, I.; Hartigan-Go, Kenneth; Lindquist, Marie; MCEWEN, John; Moride, Yola; Olsson, Sten; Pal, Shanthi; Soulaymani-Bencheikh, Rachida; Tuccori, Marco; Vaca, Claudia; Wong, Ian.

In: Drug Safety, Vol. 37, No. 10, 2014, p. 743-759.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

AU - Beckmann, Jürgen

AU - Hagemann, Ulrich

AU - Bahri, Priya

AU - Bate, Andrew

AU - Boyd, Ian

AU - Pan, Gerald

AU - Edwards, Brian

AU - Edwards, I.

AU - Hartigan-Go, Kenneth

AU - Lindquist, Marie

AU - MCEWEN, John

AU - Moride, Yola

AU - Olsson, Sten

AU - Pal, Shanthi

AU - Soulaymani-Bencheikh, Rachida

AU - Tuccori, Marco

AU - Vaca, Claudia

AU - Wong, Ian

PY - 2014

Y1 - 2014

N2 - The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognized during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in different regions of the world. Also, theoretical knowledge needs supplementing with experience and practical skills

AB - The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognized during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in different regions of the world. Also, theoretical knowledge needs supplementing with experience and practical skills

KW - pharmacovigilance

KW - safe medicines and their safe use

KW - research

KW - regulation

U2 - 10.1007/s40264-014-0216-1

DO - 10.1007/s40264-014-0216-1

M3 - Article

VL - 37

SP - 743

EP - 759

JO - Medical Toxicology and Adverse Drug Experience

JF - Medical Toxicology and Adverse Drug Experience

SN - 0114-5916

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ER -