PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA 950 F STREET, NW WASHINGTON, DC 20004 www.phrma.org | www.innovation.org 2012 profile PHARMACEUTICAL INDUSTRY Key Facts…

1. DRUG DEVELOPMENT AND REGULATION www.freelivedoctor.com 2. Historical Background Why were Laws Needed? Adulteration for economic gain Early English Law - King John promulgates…

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Slide 1U.S. Regulation of Prescription Drug Marketing and Promotion October 21, 2004 Bill Ross Slide 2 10/21/2004U.S. Regulation of Prescription Drug Marketing and Promotion…

Slide 1Orphan Diseases ECD Global Alliance October 2010 Slide 2 What is an Orphan Disease? A Disease Affecting So Few People That: –There is no reasonable expectation that…

Slide 1Chapter 2 Law and Ethics of Pharmacy Copyright © 2004 by Elsevier Inc. All rights reserved. Slide 2 Introduction Practice of pharmacy–governed by series of laws,…

1. DRUG DEVELOPMENT AND REGULATION Joseph Hanig, Ph.D. 2. Historical BackgroundWhy were Laws Needed?• Adulteration for economic gain• Early English Law - King John promulgatesrules…

1. Drug Discovery andDevelopmentHow are drugs discovered anddeveloped? 2. Basic Steps• Choose a disease• Choose a drug target• Identify a “bioassay”bioassay = A…

1. Predictors of orphan drug approvalHarald E. Heemstra, [email protected] Conference on Rare DiseasesKrakow, 15 May 201015 May 2010XxxCompany XXxxCompany…

1. Marlene E. Haffner, MD, MPHCEO, Haffner Associates, LLCCenter for Drug Research and DevelopmentU of British ColumbiaVancouver, CanadaTuesday, October 16, 2012 2. ◦…