Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
•Covers the evolving regulatory landscape, as well as current and future use of digital technologies.
•Uses case studies to ensure content is relevant to everyday practice.
•Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance.
•Consolidates today’s available information on this timely topic into one convenient resource.
Table Of Contents:
Section I. The Regulatory Enviroment
1. Does Regulation Drive Science or Does Science Drive Regulation?
Section II. Data and Real World Evidence
2. Role of Epidemiology in Pharmaceutical Industry
3. Real World Epidemiologic Studies and Patient Registries
Section III. Benefit-Risk in the Drug Development Life Cycle
4. Signal Management and Methods of Signal Detection
5. Causality Assessment and Examples of Adverse Drug Reactions (Drug Induced Liver Injury, Skin, Major Adverse Cardiac Events and Renal)
6. Product Safety Monitoring in Clinical Trials
7. Benefit-Risk Assessments
8. Communicating benefit risk
9. Pharmacovigilance and Medical Devices
10. Vaccine Safety Surveillance
11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)
12. Pharmacovigilance in Pregnancy
Section IV. The Role of the Digital Revolution
13. Impact and Implications of Technology on Pharmacovigilance
The 9th Edition of the European Pharmacopoeia (EP), main volume and supplements, is legally binding and details the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, the raw materials used in the production of medicines and on the intermediates of synthesis.
The EP is a single reference work for the quality control of medicines in Europe. All producers of medicines or substances for pharmaceutical use must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe.
? Applicable in 38 European countries and used in over 100 worldwide.
? Delivers crucial information earlier than any other Pharmacopoeia.
? Over 50% new or revised texts compared to the previous edition.
? Allows free access to the ?Knowledge? database and the online archives.
PUBLICATIONS & IMPLEMENTATION DATES
VOLUME PUBLICATION DATE IMPLEMENTATION DATE
9.6 July 2018 01 January 2019
9.7 October 2018 01 April 2019
9.8 January 2019 01 July 2019