Description
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 Enviroment1. Does Regulation Drive Science or Does Science Drive Regulation?Section II. Data and Real World Evidence2. Role of Epidemiology in Pharmaceutical Industry3. Real World Epidemiologic Studies and Patient RegistriesSection III. Benefit-Risk in the Drug Development Life Cycle4. Signal Management and Methods of Signal Detection5. 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 Trials7. Benefit-Risk Assessments8. Communicating benefit risk9. Pharmacovigilance and Medical Devices10. Vaccine Safety Surveillance11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)12. Pharmacovigilance in PregnancySection IV. The Role of the Digital Revolution13. Impact and Implications of Technology on PharmacovigilanceSection V. The Next Frontier14. The Future of Pharmacovigilance
-
- 電子書籍
- 7日でマスター FXがおもしろいくらい…
-
- 洋書電子書籍
-
イタリアの会計：歴史と伝統
Th…
