The Law and Regulation of Medicines

Thisisacomprehensivetextbookonthescience，regulatorypolicyandlawsurroundingthediscovery，developmentandmarketingofnewmedicines.Itisareferenceworkandsourceofexpertiseforlegal，medical，andpharmaceuticalprofessionalsworkinginthefieldsofmedicineregulation，medicallawandproductliability.Writtenbyanauthorteamcomprisingspecialistsinpharmaceuticalmedicine，pharmacologyandtherapeutics，andlawyersspecializinginproductliabilitylawandintellectualproperty，thisbookreviewsalltheareasofscience，regulatorypolicyandlegislation，togetherwiththeconsumerprotectionandintellectualpropertylawasapplicabletothedevelopmentandcommercializationofmedicinalproducts.Servingasapracticalintroductionforpractitionerswishingtoundertakeworkinthishighlycomplexareaoflaw，thisbookisspecificallydesignedtofacilitatedeepermutualunderstandingofthescientificandtechnicalissuesforthelawyer，andthelegalissuesforthoseinvolvedwithregulatorypolicyanddecisionmakingandseniorexecutivesinthepharmaceuticalindustry.TheworkcoverstheEuropeanandUKlegislationonmedicinesandhealthcareproducts，includingtheprincipaldirectivesandregulations，togetherwithUKimplementinglegislationandinstruments，andthekeycaselaw.Itcoversthestructureandfunctionoftheregulatoryauthorities，applicationstocarryoutclinicaltrials，intellectualpropertyissues，productliabilityissuesandlitigation.Thisbookprovidespracticalguidanceondraftingregulatorysubmissions，preparinglitigationagainstdecisionsoftheregulatoryauthorities;determiningappropriateregulatorysubmissionstrategiesthroughouttheEuropeanCommunity，andpreparinglitigationrelatingtomedicinalproductsliabilityundertheProductLiabilityDirectiveandtheConsumerProtectionAct1987.