Cobert's Manual of Drug Safety and PharmacovigilanceJones & Bartlett Publishers, 2011 - 407 pages Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem. |
Table des matières
The Theory and Definitions of Drug Safety Pharmacoviligance | 1 |
Clinical Trials Clinical Research Organizations Phases IIV and InvestigatorInitiated Trials | 7 |
Spontaneous Postmarketing Adverse Events | 15 |
The Theory of Drug Safety Pharmacovigilance | 21 |
Adverse Events with New Chemical Entities Generics Excipients Placebos and Counterfeits | 27 |
Acute and Chronic Late Occurring Adverse Events Adverse Events That Disappear Bendectin and Diethylstilbesterol | 35 |
The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology | 39 |
Where Data Reside | 45 |
Risk What Is It? Risk Management and Assessment Risk Evaluation and Minimization Systems REMS and Risk Management Plans RMPs | 187 |
The United States FDAs Three Risk Guidances of 2005 | 199 |
Data Management Committees and IRBsEthics Committees | 211 |
Product Quality Issues | 217 |
Drug Labeling | 223 |
Pregnancy and Lactation | 229 |
CIOMS | 235 |
International Conference on Harmonization ICH | 251 |
Regulations Directives Guidances and Laws | 49 |
Children Elderly and Other Special Vulnerable Groups | 55 |
Drug Interactions | 61 |
AE Volume Quality Good Documentation Procedures and Medical Records | 65 |
Seriousness Expectedness and Causality | 69 |
Coding of AEs and Drug Names | 79 |
Expedited and Aggregate Reporting in Clinical Trials | 87 |
Postmarketing Spontaneous ICSRSAE Reporting | 95 |
Periodic Adverse Drug Experience Reports PADERS NDA Periodic Reports and Periodic Safety Update Reports PSURs | 103 |
Epidemiology and Pharmacoepidemiology What Are They? What Are Their Limitations and Advantages? | 109 |
Signals and Signaling in the Context of Risk Management | 115 |
Information Technology Databases and Computers | 129 |
The United States Food and Drug Administration FDA and MedWatch | 137 |
Chapter 22 The European Medicines Agency EMA EMEA | 151 |
The Qualified Person for Pharmacovigilance | 159 |
United Kingdom Medicines and Healthcare Products Regulatory Agency MHRA | 163 |
Health CanadaSanté Canada | 167 |
Australian Therapeutic Goods Administration TGA | 169 |
The Uppsala Monitoring Centre | 171 |
Data Privacy and Security | 173 |
The Roles and Interactions of Companies Governments Nongovernmental Organizations NGOs and Others in the World of Pharmacovigilance | 179 |
Pharmaceutical Companies | 267 |
Universities and Academic Medical Centers | 271 |
Organization of a Typical Drug Safety Department | 275 |
How an Individual Case Safety Report ICSR Is Handled from Start to Finish | 283 |
The Safety Departments Role in Clinical Research Marketing and Sales Labeling Regulatory Due Diligence and Legal Issues | 293 |
SOPs Working Documents Manuals Guidelines | 301 |
Training | 307 |
Vaccinovigilance | 311 |
Toxic Effects of Immunogenicity to Biopharmaceuticals | 317 |
Business Partners and Exchange of Safety Data | 321 |
Audits and Inspections | 329 |
SummaryDescription of PV Systems and RiskBased Inspections | 337 |
Ethical Issues and Conflicts of Interest | 343 |
Vigilance of Natural Health Products | 351 |
RealWorld Issues Fialuridine | 361 |
RealWorld Issues FenPhen | 365 |
RealWorld Issues Nomifensine | 367 |
Web Resources | 369 |
Abbreviations | 395 |
| 399 | |
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Expressions et termes fréquents
ADRs adverse drug adverse drug reactions adverse reaction AE reporting approved assessment Biological causality changes Chapter CIOMS clinical research clinical trial coding countries disease document dose drug safety department drug safety group electronic ensure epidemiology EudraVigilance European Medicines Agency European Union evaluation excipients expedited reports FDA's follow-up functions guidelines handle health agencies health authorities Health Canada healthcare professionals inspections interactions International investigator brochure labeling manufacturer marketing MedDRA medicinal product MedWatch ments MHRA monitoring multiple NHPs nonserious noted patients periodic reports pharma Pharmacoepidemiology pharmacovigilance physicians placebo postmarketing pregnancy PSUR QPPV regulations regulatory REMS requirements risk management SAEs safety data safety database safety information safety issues safety reports serious AEs signal SOPs specific sponsor spontaneous reports standard studies submitted summary tion toxicity unexpected United Kingdom Uppsala Monitoring Centre usually vaccine Volume 9A website Web Resource