Good Pharmacovigilance Practice Guide

Medicines and Healthcare Products Regulatory Agency (Autor)

Buch | Softcover

232 Seiten

2008
Pharmaceutical Press (Verlag)
978-0-85369-834-0 (ISBN)

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Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines. This text provides practical advice about achieving an appropriate system of pharmacovigilance.

1. EEA Qualified Person Responsible for Pharmacovigilance; 2. Management of Pharmacovigilance Data; 3. Spontaneous Case Processing; 4. Literature Searching; 5. Periodic Safety Update Reports; 6. Evaluation of Safety Data; 7. Risk Management Plans; 8. Reference Safety Information; 9. Quality Management System; 10. Interactions Between Pharmacovigilance and Other Functions; 11. Contracts and Agreements; 12. Safety Reporting for Clinical Trials.

Erscheint lt. Verlag	18.11.2008
Verlagsort	London
Sprache	englisch
Maße	172 x 244 mm
Gewicht	454 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
ISBN-10	0-85369-834-1 / 0853698341
ISBN-13	978-0-85369-834-0 / 9780853698340
Zustand	Neuware