AN INTRODUCTION TO PHARMACOVIGILANCE, 2ND EDITION

1 Introduction – Overview – Background 1
2 Metacognition and Errors in Judgment Related to Decision ]Making in Homeland Security 15
3 Ethical, Legal, and Social Issues in Homeland Security – What They Are and How to Address Them 29
4 Strategic Environment 55
5 Extreme Right ]Wing Ideologues, Conservative Secession, and Terrorism 79
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
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
26 Applying Management and Organizational Theory Education to Create Effective Agencies 429
27 U.S. Economic Statecraft, Homeland Security, and the Trans ]Pacific Partnership 437
28 Deconstructing Latin American Security 449
29 The Power of Pop Culture in the Hands of ISIS 459

Index 469

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.

Author Information
• 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).