An Introduction to Pharmacovigilance

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).

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