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The Perception and Management of Drug Safety Risks
In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies execut...
European Medicines Research
The European Medicines Evaluation Agency was established in 1995 in London on behalf of the European Union and regulates the standardization and harmonization in medicine applications for marketing authorization from 1995 on. The European Commission has been the driving force in the anticipation of international cooperation and research for harmonization standards. This volume provides an overview of contributions from academic, regulatory and pharmaceutical world on the current state, proposed methods and strategies for future research.
Detection of New Adverse Drug Reactions
This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.
