An Introduction to Pharmacovigilance

ISBN-13: 9781119289746 / Angielski / Miękka / 2017 / 192 str.

Waller, Patrick; Harrison–Woolrych, Mira

Opis

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

Spis treści

List of Contributors ix

Acknowledgments xi

About the Companion Website xiii

1 Introduction Overview Background 1

2 Metacognition and Errors in Judgment Related to Decision ]Making in Homeland Security 15
Angi English

3 Ethical, Legal, and Social Issues in Homeland Security What They Are and How to Address Them 29
Alexander Siedschlag

4 Strategic Environment 55

5 Extreme Right ]Wing Ideologues, Conservative Secession, and Terrorism 79
Tobias T. Gibson and Richard Q. Sterns

6 Intelligence Gathering 95

7 The Department of Homeland Security 141

8 Federal Emergency Management Agency (FEMA) 159

9 National Security Strategy of the United States of America, 2006, 2015 175

10 National Strategy for Homeland Security, October 2007 181

11 National Strategy for Combating Terrorism, 2006; National Strategy for Counterterrorism, 2011 187

12 Border Security 191

13 Critical Infrastructure Protection 205

14 Cybersecurity Legislation and Critical Infrastructure Vulnerabilities 233
William A. Carter and Daniel G. Sofio

15 Agriculture and Food 251

16 Transportation Security 267

A. Overview 267

B. Aviation Security 275

C. Maritime Transportation Security 289

D. Rail Transportation 304

E. Trucking 307

F. Bus 308

17 Weapons of Mass Destruction 315

18 Biodefense and WMD Medical Countermeasures 327

19 National Continuity Policy 351

20 Identification Issues 359

I. Terrorist Screening and Airport Passenger Screening 360

II. REAL ID Act 363

III. Common Identification for Federal Employees 366

21 National Incident Management System (NIMS) and National Response Framework (NRF) 367

22 Preparedness 373

23 Resiliency and a Culture of Preparedness 397

24 Authority to Use Military Force 407

25 Creating the Guardians: The Status of Homeland Security Education 423
Laura Manning Johnson and Robert Hayhurst

26 Applying Management and Organizational Theory Education to Create Effective Agencies 429
Judson M. Freed

27 U.S. Economic Statecraft, Homeland Security, and the Trans ]Pacific Partnership 437
David A. Parker and Daniel G. Sofio

28 Deconstructing Latin American Security 449
Pablo Brum

29 The Power of Pop Culture in the Hands of ISIS 459
Joseph Russo

Index 469

O autorze

Patrick Waller MD, MPH, FRCPEd, FFPM, Formerly Honorary Professor, London School of Hygiene and Tropical Medicine, London, United Kingdom.

Mira Harrison–Woolrych BM, DM, DFFP, FRCOG, Honorary Research Associate Professor, Dunedin School of Medicine, University of Otago, New Zealand; Senior Medical Assessor, Vigilance and Risk Management, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK and Secretary General of the International Society of Pharmacovigilance (ISoP).

Blurb

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug–related problems.

This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.

Covering the basics step–by–step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

"This new edition of a clear and succinct yet comprehensive guide to the field provides exactly the right introduction for those new to the challenges and the excitement of pharmacovigilance. It conveys the importance to public health protection of an effective safety net to pick up new information, and the need for well–planned strategies to generate new evidence as an enabler of innovation."

–From the Foreword by Dr June Raine CBE, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK and Chair of the EU Pharmacovigilance Risk Assessment Committee.

Praise for the first edition
"The book is small in size, attractively produced, and... accessible to all. It does not assume any prior knowledge, yet it also manages to be informative for those who are already familiar with pharmacovigilance. I strongly recommend anyone involved with any type of post–marketing medication research, or any epidemiological study which includes medication use, to read this interesting little book."

–C. Ineke Neutel, University of Ottawa (Annals of Epidemiology, December 2010)