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Chapter-15 Pharmacovigilance Regulations in Various Countries

BOOK TITLE: Textbook of Pharmacovigilance

Author
1. Gupta SK
2. Srivastava Sushma
ISBN
9789350252062
DOI
10.5005/jp/books/11442_15
Edition
1/e
Publishing Year
2011
Pages
22
Author Affiliations
1. Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India; All India Institute of Medical Sciences (AIIMS), New Delhi, India, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
2. Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), MB Road, Pushp Vihar, Sector-3, New Delhi (India), All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India, Delhi Institute of Pharmaceutical, Sciences and Research, Pushp Vihar, Sector -3, New Delhi, India, Delhi Institute of Pharmaceutical, Sciences and Research, Pushp Vihar Sector-3, New Delhi, India, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi, New Delhi, India, Delhi Institute of Pharmaceutical Sciences and Research, University of Delhi, Pushp Vihar, Sector-3, New Delhi, India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
Chapter keywords
Sulphanilamide scandal, phocomelia, thalidomide, adverse effects, adverse drug reactions, marketing authorization, European medicines evaluation agency, European economic area, regulatory pharmacovigilance, mutual recognition procedure, Pan European regulatory forum, pharmacovigilance working party, good vigilance practice, medicines control agency, Vigilance and risk management of medicines, yellow card scheme, patient group directions, regional monitoring centres, serious adverse blood reactions and events, hemovigilance, the public health code, the social security code, Regional Pharmacovigilance Centers, International conference on harmonization(ICH), good clinical practice (GCP), ministry of health, labor and welfare, Pharmaceutical and medical safety bureau, traditional chinese medicine, Pharmaceutical affairs law, spontaneous reporting system, therapeutic goods administration, Canadian Adverse Drug Reaction Information System, federal food, Drug and Cosmetic Act

Abstract

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