Mann's Pharmacovigilance
Herausgegeben von Andrews, Elizabeth B.; Moore, Nicholas
Mann's Pharmacovigilance
Herausgegeben von Andrews, Elizabeth B.; Moore, Nicholas
- Gebundenes Buch
- Merkliste
- Auf die Merkliste
- Bewerten Bewerten
- Teilen
- Produkt teilen
- Produkterinnerung
- Produkterinnerung
Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics.
Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and…mehr
Andere Kunden interessierten sich auch für
- Ryan F DonnellyMicroneedle-Mediated Transdermal and Intradermal Drug Delivery153,99 €
- Pharmacogenomics in Clinical Therapeutics166,99 €
- Justina Orleans-LindsayPharmacovigilance Medical Writing69,99 €
- Antimicrobial Therapeutics Reviews, Volume 1213155,99 €
- Andrew BatchelderRapid Clinical Pharmacology36,99 €
- Steven JuliousAn Introduction to Statistics in Early Phase Trials124,99 €
- Nanomedicine for Drug Delivery and Therapeutics246,99 €
-
-
-
Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics.
Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field.
From an international team of expert editors and contributors, Mann's Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine.
The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field.
From an international team of expert editors and contributors, Mann's Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine.
The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Produktdetails
- Produktdetails
- Verlag: Wiley & Sons
- 3. Aufl.
- Seitenzahl: 872
- Erscheinungstermin: 23. Juni 2014
- Englisch
- Abmessung: 254mm x 192mm x 53mm
- Gewicht: 1593g
- ISBN-13: 9780470671047
- ISBN-10: 0470671041
- Artikelnr.: 34439047
- Verlag: Wiley & Sons
- 3. Aufl.
- Seitenzahl: 872
- Erscheinungstermin: 23. Juni 2014
- Englisch
- Abmessung: 254mm x 192mm x 53mm
- Gewicht: 1593g
- ISBN-13: 9780470671047
- ISBN-10: 0470671041
- Artikelnr.: 34439047
Elizabeth B. Andrews PhD, MPH, FISPE, Vice President, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA Nicholas Moore MD, PhD, FRCP(Edin), FISPE, Professor of Clinical Pharmacology, Service Hospitalo-Universitaire de Pharmacologie, Bordeaux, France
Introduction Updated from Second edition 1 History of Pharmacovigilance
Judith K. Jones and Elyse E. Kingery I The Regulatory Basis of
Pharmacovigilance 2 Legal Basis - European Union Brian Edwards, Calvin
Johnson, Shelley Gandhi 3 Ethical Oversight, Consent and Confidentiality
Suzanne L West and Wendy A Visscher 4 Pharmacovigilance-Related Topics at
the Level of the International Conference on Harmonisation Priya Bahri 5
CIOMS Working Groups and their Contributions to Pharmacovigilance Gunilla
Sjölin-Forsberg and William Gregory 6 Terminologies in Pharmacovigilance
Elliot Brown and Daniel von Sydow 7 Non-Clinical Toxicological Support for
Phase I Trials David R Jones and JW McBlane 8 The Evaluation of Adverse
Events in Clinical Trials Jesse A. Berlin, Brenda Crowe and Amy Xia 9 Case
Reports as Evidence in Pharmacovigilance J K Aronson and William Kelly 10
Periodic Safety Update Reports Patrice Verpillat and Mondher Toumi 11 The
Principles behind Risk Management in the EU Stella CF Blackburn, June M
Raine II Spontaneous Reporting Systems 12 Pharmacovigilance in Europe 12
Regulatory Pharmacovigilance in the European Union Priya Bahri a
Spontaneous Reporting - United Kingdom Sarah Davis, Bridget King and June
M. Raine b Spontaneous Reporting - France Jacques Caron, Sophie Gautier and
Michel Mallaret c How Pharmacovigilance is Organized in Germany Ulrich
Hagemann and Norbert Paeschke d Organisation of Pharmacovigilance in the
Netherlands Eugène van Puijenbroek and Kees van Grootheest e
Pharmacovigilance in Spain Dolores Montero, Miguel Angel Maciá and César de
la Fuente f Italian Pharmacovigilance System Laura Sottosanti g
Pharmacovigilance in Turkey Sinem Ezgi Gülmez 13 Pharmacovigilance in the
Americas a Spontaneous Reporting and Pharmacovigilance Practice - United
States Min-Chu Chen, Solomon Iyasu, Alfred Sorbello and Linda Scarazzini b
Spontaneous Reporting in Mexico Alejandra Rosete and Ricardo
Benítez-Vázquez c Pharmacovigilance in Argentina: A lot done, a lot to do
Luis Alesso and Raquel Herrera Comoglio 14 Pharmacovigilance in Asia a
Pharmacovigilance and Risk Management in Japan Kiyoshi Kubota b
Pharmacovigilance in Hong Kong Thomas Y.K. Chan c Pharmacovigilance in
China Fan-Dian Zeng, Jie Tang and Hong-Hao Zhou d China Kenneth Hartigan-Go
and Althea G Bongat e Malaysia Kenneth Hartigan-Go and Althea G Bongat f
Philippines Kenneth Hartigan-Go and Althea G Bongat g Singapore Kenneth
Hartigan-Go and Althea G Bongat h Thailand Kenneth Hartigan-Go and Althea G
Bongat i Vietnam Kenneth Hartigan-Go and Althea G Bongat j
Pharmacovigilance in India - The Use of Allopathic and Ayurvedic Medicines
Pippa Biswas 15 Pharmacovigilance in New Zealand and Australia a
Pharmacovigilance in New Zealand Mira Harrison-Woolrych, Michael Tatley and
Desiree L Kunac b Pharmacovigilance - Australia. John McEwen 16
Pharmacovigilance in Africa Alexander N. O. Dodoo 17 Vaccine Safety
Surveillance Emily Jane Woo, Jerry Labadie and M. Miles Braun III Signal
Detection/Generation in Spontaneous Reporting Programs and Other
Sources: From Spontaneous Reporting to Pharmacoepidemiology 18 Assessing
Suspected Adverse Event Causality Judith K Jones and Elyse Kingery 19
Quantitative Signal Detection and Analysis in Pharmacovigilance Andrew
Bate, A Pariente, M Hauben and B Bégaud 20 Self-Controlled Case Series
Analysis Paddy Farrington 21 Prescription-Event Monitoring (PEM) - the
Evolution to the New Modified PEM and its Support of Risk Management
Deborah Layton and Saad Shakir 22 Prescription Event Monitoring (PEM) in
New Zealand Mira Harrison-Woolrych 23 A Description of ENCePP as a Global
Resource for Pharmacovigilance and Pharmacoepidemiology Thomas Goedecke and
Peter Arlett 24 Overview of North American Databases Brian L. Strom, Rita
Schinnar and Judith L. Kinman 25 The Clinical Practice Research Datalink
(CPRD) The New 52M Fully Integrated Research Data and Clinical Trial System
John Parkinson 26 Active Surveillance: The United States Food and Drug
Administration's Sentinel Initiative Ryan M. Carnahan, Carlos J. Bell and
Richard Platt 27 Leveraging Routinely Collected Healthcare Data to Scale Up
Drug Safety Surveillance: the European Union-Adverse Drug Reaction
Experience Gianluca Trifiró & Preciosa Coloma 28 Development and Evaluation
of Infrastructure and Analytic Methods for Systematic Drug Safety
Surveillance: Lessons and Resources from the Observational Medical Outcomes
Partnership Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J
Marc Overhage, Emily Welebob, Christian G. Reich, Thomas Scarnecchia IV
Pharmacovigilance and Drug/System Organ Classes 29 Mechanisms of Adverse
Drug Reactions Munir Pirmohamed 30 Fatal Medication Errors and Adverse Drug
Reactions Robin E. Ferner and Sarah E. McDowell 31 Dermatological Adverse
Drug Reactions Laurence Valeyrie-Allanore and Jean-Claude Roujeau 32
Gastrointestinal Adverse Drug Reactions Angel Lanas Arbeloa and Carlos
Sostres Homedes 33 Haematological Adverse Drug Reactions Peter J. Carey 34
Hepatic Adverse Drug Reactions Guruprasad P. Aithal and Dominique Larrey 35
Ocular Side Effects Frederick W. Fraunfelder 36 Renal Adverse Drug
Reactions Gert A. Verpooten 37 The Cardiovascular Spectrum of Adverse Drug
Reactions Charles Schubert and Judith Hsia 38 Neurological Adverse Events
Bradford B Walters Special Populations 39 Drug Safety in Pregnancy
Christina D. Chambers and Elizabeth B. Andrews 40 Pharmacovigilance in
Pediatrics Dianne Murphy, Judith Cope and Solomon Iyasu 41 Drugs and the
Elderly Jamie J Coleman Special Product Classes 42 Anaesthetic Drug
Reactions Karine Nouette-Gaulain 43 Pharmacoepidemiology as Part of
Pharmacovigilance for Biologic Therapies John Acquavella, Brian Bradbury,
Cathy Critchlow, Jason Litten, J. Michael Sprafka and John Sullivan 44
Surveillance for Medical Devices - United States Thomas P. Gross V Current
Topics 45 The Efficacy and Safety of Selective Serotonin Reuptake
Inhibitors (SSRIs) for the Treatment of Depression in Children and
Adolescents Julie Magno Zito, DJ Safer and Satish Valluri 46 NSAIDs - COX-2
Inhibitors - Risks and Benefits K Arnold Chan and S Christopher Jones 47
Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence
to Prescribed Drug Dosing Regimens and some of their Clinical and Economic
Consequences John Urquhart and Bernard Vrijens 48 Design and Implementation
of Surveys to Assess Patient and Health Care Provider Understanding of
Risks and Safe Use Conditions Kelly Hollis and Alicia Gilsenan VI Training
and Education and Directions 49 Eu2P: The First European Online Public
Private joint Training Programme in Pharmacovigilance and
Pharmacoepidemiology Karine Palin, Christa Bataille, Stéphane Liège, Ralph
Schimmer and Annie Fourrier-Réglat (on behalf of the Eu2P consortium) 50
Teaching and Learning Pharmacovigilance Frank May 51 Practical Experience
in Teaching Pharmacovigilance Stephen Evans 52 The past, present and future
of pharmacovigilance Nicholas Moore
Judith K. Jones and Elyse E. Kingery I The Regulatory Basis of
Pharmacovigilance 2 Legal Basis - European Union Brian Edwards, Calvin
Johnson, Shelley Gandhi 3 Ethical Oversight, Consent and Confidentiality
Suzanne L West and Wendy A Visscher 4 Pharmacovigilance-Related Topics at
the Level of the International Conference on Harmonisation Priya Bahri 5
CIOMS Working Groups and their Contributions to Pharmacovigilance Gunilla
Sjölin-Forsberg and William Gregory 6 Terminologies in Pharmacovigilance
Elliot Brown and Daniel von Sydow 7 Non-Clinical Toxicological Support for
Phase I Trials David R Jones and JW McBlane 8 The Evaluation of Adverse
Events in Clinical Trials Jesse A. Berlin, Brenda Crowe and Amy Xia 9 Case
Reports as Evidence in Pharmacovigilance J K Aronson and William Kelly 10
Periodic Safety Update Reports Patrice Verpillat and Mondher Toumi 11 The
Principles behind Risk Management in the EU Stella CF Blackburn, June M
Raine II Spontaneous Reporting Systems 12 Pharmacovigilance in Europe 12
Regulatory Pharmacovigilance in the European Union Priya Bahri a
Spontaneous Reporting - United Kingdom Sarah Davis, Bridget King and June
M. Raine b Spontaneous Reporting - France Jacques Caron, Sophie Gautier and
Michel Mallaret c How Pharmacovigilance is Organized in Germany Ulrich
Hagemann and Norbert Paeschke d Organisation of Pharmacovigilance in the
Netherlands Eugène van Puijenbroek and Kees van Grootheest e
Pharmacovigilance in Spain Dolores Montero, Miguel Angel Maciá and César de
la Fuente f Italian Pharmacovigilance System Laura Sottosanti g
Pharmacovigilance in Turkey Sinem Ezgi Gülmez 13 Pharmacovigilance in the
Americas a Spontaneous Reporting and Pharmacovigilance Practice - United
States Min-Chu Chen, Solomon Iyasu, Alfred Sorbello and Linda Scarazzini b
Spontaneous Reporting in Mexico Alejandra Rosete and Ricardo
Benítez-Vázquez c Pharmacovigilance in Argentina: A lot done, a lot to do
Luis Alesso and Raquel Herrera Comoglio 14 Pharmacovigilance in Asia a
Pharmacovigilance and Risk Management in Japan Kiyoshi Kubota b
Pharmacovigilance in Hong Kong Thomas Y.K. Chan c Pharmacovigilance in
China Fan-Dian Zeng, Jie Tang and Hong-Hao Zhou d China Kenneth Hartigan-Go
and Althea G Bongat e Malaysia Kenneth Hartigan-Go and Althea G Bongat f
Philippines Kenneth Hartigan-Go and Althea G Bongat g Singapore Kenneth
Hartigan-Go and Althea G Bongat h Thailand Kenneth Hartigan-Go and Althea G
Bongat i Vietnam Kenneth Hartigan-Go and Althea G Bongat j
Pharmacovigilance in India - The Use of Allopathic and Ayurvedic Medicines
Pippa Biswas 15 Pharmacovigilance in New Zealand and Australia a
Pharmacovigilance in New Zealand Mira Harrison-Woolrych, Michael Tatley and
Desiree L Kunac b Pharmacovigilance - Australia. John McEwen 16
Pharmacovigilance in Africa Alexander N. O. Dodoo 17 Vaccine Safety
Surveillance Emily Jane Woo, Jerry Labadie and M. Miles Braun III Signal
Detection/Generation in Spontaneous Reporting Programs and Other
Sources: From Spontaneous Reporting to Pharmacoepidemiology 18 Assessing
Suspected Adverse Event Causality Judith K Jones and Elyse Kingery 19
Quantitative Signal Detection and Analysis in Pharmacovigilance Andrew
Bate, A Pariente, M Hauben and B Bégaud 20 Self-Controlled Case Series
Analysis Paddy Farrington 21 Prescription-Event Monitoring (PEM) - the
Evolution to the New Modified PEM and its Support of Risk Management
Deborah Layton and Saad Shakir 22 Prescription Event Monitoring (PEM) in
New Zealand Mira Harrison-Woolrych 23 A Description of ENCePP as a Global
Resource for Pharmacovigilance and Pharmacoepidemiology Thomas Goedecke and
Peter Arlett 24 Overview of North American Databases Brian L. Strom, Rita
Schinnar and Judith L. Kinman 25 The Clinical Practice Research Datalink
(CPRD) The New 52M Fully Integrated Research Data and Clinical Trial System
John Parkinson 26 Active Surveillance: The United States Food and Drug
Administration's Sentinel Initiative Ryan M. Carnahan, Carlos J. Bell and
Richard Platt 27 Leveraging Routinely Collected Healthcare Data to Scale Up
Drug Safety Surveillance: the European Union-Adverse Drug Reaction
Experience Gianluca Trifiró & Preciosa Coloma 28 Development and Evaluation
of Infrastructure and Analytic Methods for Systematic Drug Safety
Surveillance: Lessons and Resources from the Observational Medical Outcomes
Partnership Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J
Marc Overhage, Emily Welebob, Christian G. Reich, Thomas Scarnecchia IV
Pharmacovigilance and Drug/System Organ Classes 29 Mechanisms of Adverse
Drug Reactions Munir Pirmohamed 30 Fatal Medication Errors and Adverse Drug
Reactions Robin E. Ferner and Sarah E. McDowell 31 Dermatological Adverse
Drug Reactions Laurence Valeyrie-Allanore and Jean-Claude Roujeau 32
Gastrointestinal Adverse Drug Reactions Angel Lanas Arbeloa and Carlos
Sostres Homedes 33 Haematological Adverse Drug Reactions Peter J. Carey 34
Hepatic Adverse Drug Reactions Guruprasad P. Aithal and Dominique Larrey 35
Ocular Side Effects Frederick W. Fraunfelder 36 Renal Adverse Drug
Reactions Gert A. Verpooten 37 The Cardiovascular Spectrum of Adverse Drug
Reactions Charles Schubert and Judith Hsia 38 Neurological Adverse Events
Bradford B Walters Special Populations 39 Drug Safety in Pregnancy
Christina D. Chambers and Elizabeth B. Andrews 40 Pharmacovigilance in
Pediatrics Dianne Murphy, Judith Cope and Solomon Iyasu 41 Drugs and the
Elderly Jamie J Coleman Special Product Classes 42 Anaesthetic Drug
Reactions Karine Nouette-Gaulain 43 Pharmacoepidemiology as Part of
Pharmacovigilance for Biologic Therapies John Acquavella, Brian Bradbury,
Cathy Critchlow, Jason Litten, J. Michael Sprafka and John Sullivan 44
Surveillance for Medical Devices - United States Thomas P. Gross V Current
Topics 45 The Efficacy and Safety of Selective Serotonin Reuptake
Inhibitors (SSRIs) for the Treatment of Depression in Children and
Adolescents Julie Magno Zito, DJ Safer and Satish Valluri 46 NSAIDs - COX-2
Inhibitors - Risks and Benefits K Arnold Chan and S Christopher Jones 47
Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence
to Prescribed Drug Dosing Regimens and some of their Clinical and Economic
Consequences John Urquhart and Bernard Vrijens 48 Design and Implementation
of Surveys to Assess Patient and Health Care Provider Understanding of
Risks and Safe Use Conditions Kelly Hollis and Alicia Gilsenan VI Training
and Education and Directions 49 Eu2P: The First European Online Public
Private joint Training Programme in Pharmacovigilance and
Pharmacoepidemiology Karine Palin, Christa Bataille, Stéphane Liège, Ralph
Schimmer and Annie Fourrier-Réglat (on behalf of the Eu2P consortium) 50
Teaching and Learning Pharmacovigilance Frank May 51 Practical Experience
in Teaching Pharmacovigilance Stephen Evans 52 The past, present and future
of pharmacovigilance Nicholas Moore
Introduction Updated from Second edition 1 History of Pharmacovigilance
Judith K. Jones and Elyse E. Kingery I The Regulatory Basis of
Pharmacovigilance 2 Legal Basis - European Union Brian Edwards, Calvin
Johnson, Shelley Gandhi 3 Ethical Oversight, Consent and Confidentiality
Suzanne L West and Wendy A Visscher 4 Pharmacovigilance-Related Topics at
the Level of the International Conference on Harmonisation Priya Bahri 5
CIOMS Working Groups and their Contributions to Pharmacovigilance Gunilla
Sjölin-Forsberg and William Gregory 6 Terminologies in Pharmacovigilance
Elliot Brown and Daniel von Sydow 7 Non-Clinical Toxicological Support for
Phase I Trials David R Jones and JW McBlane 8 The Evaluation of Adverse
Events in Clinical Trials Jesse A. Berlin, Brenda Crowe and Amy Xia 9 Case
Reports as Evidence in Pharmacovigilance J K Aronson and William Kelly 10
Periodic Safety Update Reports Patrice Verpillat and Mondher Toumi 11 The
Principles behind Risk Management in the EU Stella CF Blackburn, June M
Raine II Spontaneous Reporting Systems 12 Pharmacovigilance in Europe 12
Regulatory Pharmacovigilance in the European Union Priya Bahri a
Spontaneous Reporting - United Kingdom Sarah Davis, Bridget King and June
M. Raine b Spontaneous Reporting - France Jacques Caron, Sophie Gautier and
Michel Mallaret c How Pharmacovigilance is Organized in Germany Ulrich
Hagemann and Norbert Paeschke d Organisation of Pharmacovigilance in the
Netherlands Eugène van Puijenbroek and Kees van Grootheest e
Pharmacovigilance in Spain Dolores Montero, Miguel Angel Maciá and César de
la Fuente f Italian Pharmacovigilance System Laura Sottosanti g
Pharmacovigilance in Turkey Sinem Ezgi Gülmez 13 Pharmacovigilance in the
Americas a Spontaneous Reporting and Pharmacovigilance Practice - United
States Min-Chu Chen, Solomon Iyasu, Alfred Sorbello and Linda Scarazzini b
Spontaneous Reporting in Mexico Alejandra Rosete and Ricardo
Benítez-Vázquez c Pharmacovigilance in Argentina: A lot done, a lot to do
Luis Alesso and Raquel Herrera Comoglio 14 Pharmacovigilance in Asia a
Pharmacovigilance and Risk Management in Japan Kiyoshi Kubota b
Pharmacovigilance in Hong Kong Thomas Y.K. Chan c Pharmacovigilance in
China Fan-Dian Zeng, Jie Tang and Hong-Hao Zhou d China Kenneth Hartigan-Go
and Althea G Bongat e Malaysia Kenneth Hartigan-Go and Althea G Bongat f
Philippines Kenneth Hartigan-Go and Althea G Bongat g Singapore Kenneth
Hartigan-Go and Althea G Bongat h Thailand Kenneth Hartigan-Go and Althea G
Bongat i Vietnam Kenneth Hartigan-Go and Althea G Bongat j
Pharmacovigilance in India - The Use of Allopathic and Ayurvedic Medicines
Pippa Biswas 15 Pharmacovigilance in New Zealand and Australia a
Pharmacovigilance in New Zealand Mira Harrison-Woolrych, Michael Tatley and
Desiree L Kunac b Pharmacovigilance - Australia. John McEwen 16
Pharmacovigilance in Africa Alexander N. O. Dodoo 17 Vaccine Safety
Surveillance Emily Jane Woo, Jerry Labadie and M. Miles Braun III Signal
Detection/Generation in Spontaneous Reporting Programs and Other
Sources: From Spontaneous Reporting to Pharmacoepidemiology 18 Assessing
Suspected Adverse Event Causality Judith K Jones and Elyse Kingery 19
Quantitative Signal Detection and Analysis in Pharmacovigilance Andrew
Bate, A Pariente, M Hauben and B Bégaud 20 Self-Controlled Case Series
Analysis Paddy Farrington 21 Prescription-Event Monitoring (PEM) - the
Evolution to the New Modified PEM and its Support of Risk Management
Deborah Layton and Saad Shakir 22 Prescription Event Monitoring (PEM) in
New Zealand Mira Harrison-Woolrych 23 A Description of ENCePP as a Global
Resource for Pharmacovigilance and Pharmacoepidemiology Thomas Goedecke and
Peter Arlett 24 Overview of North American Databases Brian L. Strom, Rita
Schinnar and Judith L. Kinman 25 The Clinical Practice Research Datalink
(CPRD) The New 52M Fully Integrated Research Data and Clinical Trial System
John Parkinson 26 Active Surveillance: The United States Food and Drug
Administration's Sentinel Initiative Ryan M. Carnahan, Carlos J. Bell and
Richard Platt 27 Leveraging Routinely Collected Healthcare Data to Scale Up
Drug Safety Surveillance: the European Union-Adverse Drug Reaction
Experience Gianluca Trifiró & Preciosa Coloma 28 Development and Evaluation
of Infrastructure and Analytic Methods for Systematic Drug Safety
Surveillance: Lessons and Resources from the Observational Medical Outcomes
Partnership Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J
Marc Overhage, Emily Welebob, Christian G. Reich, Thomas Scarnecchia IV
Pharmacovigilance and Drug/System Organ Classes 29 Mechanisms of Adverse
Drug Reactions Munir Pirmohamed 30 Fatal Medication Errors and Adverse Drug
Reactions Robin E. Ferner and Sarah E. McDowell 31 Dermatological Adverse
Drug Reactions Laurence Valeyrie-Allanore and Jean-Claude Roujeau 32
Gastrointestinal Adverse Drug Reactions Angel Lanas Arbeloa and Carlos
Sostres Homedes 33 Haematological Adverse Drug Reactions Peter J. Carey 34
Hepatic Adverse Drug Reactions Guruprasad P. Aithal and Dominique Larrey 35
Ocular Side Effects Frederick W. Fraunfelder 36 Renal Adverse Drug
Reactions Gert A. Verpooten 37 The Cardiovascular Spectrum of Adverse Drug
Reactions Charles Schubert and Judith Hsia 38 Neurological Adverse Events
Bradford B Walters Special Populations 39 Drug Safety in Pregnancy
Christina D. Chambers and Elizabeth B. Andrews 40 Pharmacovigilance in
Pediatrics Dianne Murphy, Judith Cope and Solomon Iyasu 41 Drugs and the
Elderly Jamie J Coleman Special Product Classes 42 Anaesthetic Drug
Reactions Karine Nouette-Gaulain 43 Pharmacoepidemiology as Part of
Pharmacovigilance for Biologic Therapies John Acquavella, Brian Bradbury,
Cathy Critchlow, Jason Litten, J. Michael Sprafka and John Sullivan 44
Surveillance for Medical Devices - United States Thomas P. Gross V Current
Topics 45 The Efficacy and Safety of Selective Serotonin Reuptake
Inhibitors (SSRIs) for the Treatment of Depression in Children and
Adolescents Julie Magno Zito, DJ Safer and Satish Valluri 46 NSAIDs - COX-2
Inhibitors - Risks and Benefits K Arnold Chan and S Christopher Jones 47
Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence
to Prescribed Drug Dosing Regimens and some of their Clinical and Economic
Consequences John Urquhart and Bernard Vrijens 48 Design and Implementation
of Surveys to Assess Patient and Health Care Provider Understanding of
Risks and Safe Use Conditions Kelly Hollis and Alicia Gilsenan VI Training
and Education and Directions 49 Eu2P: The First European Online Public
Private joint Training Programme in Pharmacovigilance and
Pharmacoepidemiology Karine Palin, Christa Bataille, Stéphane Liège, Ralph
Schimmer and Annie Fourrier-Réglat (on behalf of the Eu2P consortium) 50
Teaching and Learning Pharmacovigilance Frank May 51 Practical Experience
in Teaching Pharmacovigilance Stephen Evans 52 The past, present and future
of pharmacovigilance Nicholas Moore
Judith K. Jones and Elyse E. Kingery I The Regulatory Basis of
Pharmacovigilance 2 Legal Basis - European Union Brian Edwards, Calvin
Johnson, Shelley Gandhi 3 Ethical Oversight, Consent and Confidentiality
Suzanne L West and Wendy A Visscher 4 Pharmacovigilance-Related Topics at
the Level of the International Conference on Harmonisation Priya Bahri 5
CIOMS Working Groups and their Contributions to Pharmacovigilance Gunilla
Sjölin-Forsberg and William Gregory 6 Terminologies in Pharmacovigilance
Elliot Brown and Daniel von Sydow 7 Non-Clinical Toxicological Support for
Phase I Trials David R Jones and JW McBlane 8 The Evaluation of Adverse
Events in Clinical Trials Jesse A. Berlin, Brenda Crowe and Amy Xia 9 Case
Reports as Evidence in Pharmacovigilance J K Aronson and William Kelly 10
Periodic Safety Update Reports Patrice Verpillat and Mondher Toumi 11 The
Principles behind Risk Management in the EU Stella CF Blackburn, June M
Raine II Spontaneous Reporting Systems 12 Pharmacovigilance in Europe 12
Regulatory Pharmacovigilance in the European Union Priya Bahri a
Spontaneous Reporting - United Kingdom Sarah Davis, Bridget King and June
M. Raine b Spontaneous Reporting - France Jacques Caron, Sophie Gautier and
Michel Mallaret c How Pharmacovigilance is Organized in Germany Ulrich
Hagemann and Norbert Paeschke d Organisation of Pharmacovigilance in the
Netherlands Eugène van Puijenbroek and Kees van Grootheest e
Pharmacovigilance in Spain Dolores Montero, Miguel Angel Maciá and César de
la Fuente f Italian Pharmacovigilance System Laura Sottosanti g
Pharmacovigilance in Turkey Sinem Ezgi Gülmez 13 Pharmacovigilance in the
Americas a Spontaneous Reporting and Pharmacovigilance Practice - United
States Min-Chu Chen, Solomon Iyasu, Alfred Sorbello and Linda Scarazzini b
Spontaneous Reporting in Mexico Alejandra Rosete and Ricardo
Benítez-Vázquez c Pharmacovigilance in Argentina: A lot done, a lot to do
Luis Alesso and Raquel Herrera Comoglio 14 Pharmacovigilance in Asia a
Pharmacovigilance and Risk Management in Japan Kiyoshi Kubota b
Pharmacovigilance in Hong Kong Thomas Y.K. Chan c Pharmacovigilance in
China Fan-Dian Zeng, Jie Tang and Hong-Hao Zhou d China Kenneth Hartigan-Go
and Althea G Bongat e Malaysia Kenneth Hartigan-Go and Althea G Bongat f
Philippines Kenneth Hartigan-Go and Althea G Bongat g Singapore Kenneth
Hartigan-Go and Althea G Bongat h Thailand Kenneth Hartigan-Go and Althea G
Bongat i Vietnam Kenneth Hartigan-Go and Althea G Bongat j
Pharmacovigilance in India - The Use of Allopathic and Ayurvedic Medicines
Pippa Biswas 15 Pharmacovigilance in New Zealand and Australia a
Pharmacovigilance in New Zealand Mira Harrison-Woolrych, Michael Tatley and
Desiree L Kunac b Pharmacovigilance - Australia. John McEwen 16
Pharmacovigilance in Africa Alexander N. O. Dodoo 17 Vaccine Safety
Surveillance Emily Jane Woo, Jerry Labadie and M. Miles Braun III Signal
Detection/Generation in Spontaneous Reporting Programs and Other
Sources: From Spontaneous Reporting to Pharmacoepidemiology 18 Assessing
Suspected Adverse Event Causality Judith K Jones and Elyse Kingery 19
Quantitative Signal Detection and Analysis in Pharmacovigilance Andrew
Bate, A Pariente, M Hauben and B Bégaud 20 Self-Controlled Case Series
Analysis Paddy Farrington 21 Prescription-Event Monitoring (PEM) - the
Evolution to the New Modified PEM and its Support of Risk Management
Deborah Layton and Saad Shakir 22 Prescription Event Monitoring (PEM) in
New Zealand Mira Harrison-Woolrych 23 A Description of ENCePP as a Global
Resource for Pharmacovigilance and Pharmacoepidemiology Thomas Goedecke and
Peter Arlett 24 Overview of North American Databases Brian L. Strom, Rita
Schinnar and Judith L. Kinman 25 The Clinical Practice Research Datalink
(CPRD) The New 52M Fully Integrated Research Data and Clinical Trial System
John Parkinson 26 Active Surveillance: The United States Food and Drug
Administration's Sentinel Initiative Ryan M. Carnahan, Carlos J. Bell and
Richard Platt 27 Leveraging Routinely Collected Healthcare Data to Scale Up
Drug Safety Surveillance: the European Union-Adverse Drug Reaction
Experience Gianluca Trifiró & Preciosa Coloma 28 Development and Evaluation
of Infrastructure and Analytic Methods for Systematic Drug Safety
Surveillance: Lessons and Resources from the Observational Medical Outcomes
Partnership Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J
Marc Overhage, Emily Welebob, Christian G. Reich, Thomas Scarnecchia IV
Pharmacovigilance and Drug/System Organ Classes 29 Mechanisms of Adverse
Drug Reactions Munir Pirmohamed 30 Fatal Medication Errors and Adverse Drug
Reactions Robin E. Ferner and Sarah E. McDowell 31 Dermatological Adverse
Drug Reactions Laurence Valeyrie-Allanore and Jean-Claude Roujeau 32
Gastrointestinal Adverse Drug Reactions Angel Lanas Arbeloa and Carlos
Sostres Homedes 33 Haematological Adverse Drug Reactions Peter J. Carey 34
Hepatic Adverse Drug Reactions Guruprasad P. Aithal and Dominique Larrey 35
Ocular Side Effects Frederick W. Fraunfelder 36 Renal Adverse Drug
Reactions Gert A. Verpooten 37 The Cardiovascular Spectrum of Adverse Drug
Reactions Charles Schubert and Judith Hsia 38 Neurological Adverse Events
Bradford B Walters Special Populations 39 Drug Safety in Pregnancy
Christina D. Chambers and Elizabeth B. Andrews 40 Pharmacovigilance in
Pediatrics Dianne Murphy, Judith Cope and Solomon Iyasu 41 Drugs and the
Elderly Jamie J Coleman Special Product Classes 42 Anaesthetic Drug
Reactions Karine Nouette-Gaulain 43 Pharmacoepidemiology as Part of
Pharmacovigilance for Biologic Therapies John Acquavella, Brian Bradbury,
Cathy Critchlow, Jason Litten, J. Michael Sprafka and John Sullivan 44
Surveillance for Medical Devices - United States Thomas P. Gross V Current
Topics 45 The Efficacy and Safety of Selective Serotonin Reuptake
Inhibitors (SSRIs) for the Treatment of Depression in Children and
Adolescents Julie Magno Zito, DJ Safer and Satish Valluri 46 NSAIDs - COX-2
Inhibitors - Risks and Benefits K Arnold Chan and S Christopher Jones 47
Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence
to Prescribed Drug Dosing Regimens and some of their Clinical and Economic
Consequences John Urquhart and Bernard Vrijens 48 Design and Implementation
of Surveys to Assess Patient and Health Care Provider Understanding of
Risks and Safe Use Conditions Kelly Hollis and Alicia Gilsenan VI Training
and Education and Directions 49 Eu2P: The First European Online Public
Private joint Training Programme in Pharmacovigilance and
Pharmacoepidemiology Karine Palin, Christa Bataille, Stéphane Liège, Ralph
Schimmer and Annie Fourrier-Réglat (on behalf of the Eu2P consortium) 50
Teaching and Learning Pharmacovigilance Frank May 51 Practical Experience
in Teaching Pharmacovigilance Stephen Evans 52 The past, present and future
of pharmacovigilance Nicholas Moore