ÿþ<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Strict//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-strict.dtd"> <html xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><head><title>Amarex Clinical Research - Staff Articles & Presentations</title> <meta http-equiv="Content-Type" content="text/html; charset=UTF-8" /> <link rel="stylesheet" href="/css/screen.css" type="text/css" media="screen" /> <link rel="stylesheet" href="/css/print.css" type="text/css" media="print" /></head> <body class="articles"> <div class="document-wrap"> <div class="document"> <div class="header"> <h1><a href="/">Amarex Clinical Research</a></h1> <h2>Managing Clinical Trials with Speed and Precision</h2> </div> <div class="site-navigation"> <ul> <li><a id="home" href="/" title="Home">Home</a></li> <li><a id="company" href="/company/" title="Company">Company</a></li> <li><a id="services" href="/services/" title="Services">Services</a></li> <li><a id="experience" href="/experience/" title="Experience">Experience</a></li> <li><a id="contact" href="/contact/" title="Contact">Contact</a></li> </ul> </div> <div class="body"> <ul class="local-navigation"> <li><a id="calendar" href="/calendar/" title="Calendar of Events">Calendar of Events</a></li> <li><a id="news" href="/news/" title="News">News</a></li> <li><a id="articles" href="/articles/" title="Articles &amp; Presentations">Articles &amp; Presentations</a></li> <li><a id="regulatory" href="/regulatory/" title="ICH Guidance and FDA Regulatory Guidelines &amp; Updates">ICH Guidance and <br /> FDA Regulatory <br /> Guidelines &amp; Updates</a></li> <li><a id="jobs" href="../ExternalSite1/career.aspx" title="Job Openings">Job Openings</a></li> <li><a id="webview" href="https://www.amarexcro.com/webview/" title="WebView Login and Registration">WebView<sup>SM</sup></a></li> <li><a id="registration" href="https://www.amarexcro.com/webview/ClinicalSiteReg/CSORSignInReg.aspx" title="Clinical Sites Registration">Clinical Sites Registration</a></li> </ul> <div class="content"> <h3>Staff Articles &amp;&nbsp;Presentations</h3> <p>We hope some of the following articles and presentations provide you with useful information on different aspects of clinical product development. Please note that these files are in PDF format. If needed, download a PDF reader from the link at the bottom of the page.</p> <p style="font-weight: bold;">ARTICLES</p> <p><a target="_blank" href="docs/RAPS_Focus_Global_Dev_Dec2011.pdf">Global Development of an Innovative Medical Device for the U.S. Market</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Preclinical_Global_Dec2011.pdf">Risks and Benefits of Conducting Preclinical Studies in the Global Setting</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Wound_Products_Dec2011.pdf">Development of Wound Management Products for the U.S.</a></p> <p><a target="_blank" href="docs/RAPS_Focus_FDA_Audits_Oct2011.pdf">An FDA Audit Is Good for You</a></p> <p><a target="_blank" href="docs/RAPS_Focus_SOPs_Oct2011.pdf">SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Dispute_Resolution_with_FDA_Mar2011.pdf">Resolving Scientific Disputes with FDA</a></p> <p><a target="_blank" href="docs/RAPS_Focus_GMP_for_Dietary_Supp_Feb2011.pdf">Strategies for Implementing the New GMPs for Dietary Supplements</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Meeting_with_FDA_Oct2010.pdf">Meeting with FDA Can Increase the Probability of Product Approval</a></p> <p><a target="_blank" href="docs/Business_Times_India_Take_Lead.pdf">The Strategy Is Not Generic</a></p> <p><a target="_blank" href="docs/RAPS_Focus_505b2_Apr2010.pdf">The 505(b)(2) Drug Development Pathway</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Biosimilars_Apr2010.pdf">Biosimilars: Past, Present and Future</a></p> <p><a target="_blank" href="docs/RAPS_Focus_ChineseMeds_BotDrugs_Aug2009.pdf">Developing Traditional Chinese Medicines as Botanical Drugs for the US Market</a></p> <p><a target="_blank" href="docs/RAPS_Focus_DevBot_India_Aug2009.pdf">Developing Botanical Products from India for the US Market</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Practical_Feb2009.pdf">Practical Aspects of Conducting Clinical Trials in India</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Gap_Dec2008.pdf">Forecasting for Success: The Power of Regulatory Gap Analysis</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Innovation_Oct2008.pdf">Energizing Innovation</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Outsourcing_Oct2008.pdf">Considering Outsourcing?</a></p> <p><a target="_blank" href="docs/RAPS_Harmonization_Jun2008.pdf">Regulatory Harmonization Efforts in India: Keeping in Step With the Globe</a></p> <p><a target="_blank" href="docs/RAPS_Strategy_Jun2008.pdf">Designing a Global Product Development Strategy</a></p> <p><a target="_blank" href="docs/RAPS_Focus_Mar2007.pdf">Regulatory Considerations for Conducting Clinical Trials In India</a><span style="text-decoration: underline;"></span></p> <p><span style="text-decoration: underline;"></span><a target="_blank" href="docs/RAPS_Biogenerics_Jan08.pdf">The Promise of Biogenerics: Hope and Hype</a></p> <p style="font-weight: bold;">ARTICLES IN CHINESE</p> <p><a target="_blank" href="docs/°eoƒ3u÷‹ºNNŽýVߘÁTŒToƒir¡{t@\„v^—lQ_'`O®‹.pdf">Close Meeting With U.S. Food and Drug Administration for New Drug Development</a></p> <p><a target="_blank" href="docs/ŽýVߘÁTŒToƒir¡{t@\ÍyIƒoƒ°eoƒ4NŠ^Õ‹Œš3u÷‹.pdf">Investigational New Drug Application of Chinese Herbal Medicine in U.S. and Regulatory Requirements of U.S. Food and Drug Administration</a></p> <p><span style="font-weight: bold;"></span></p><p><span style="font-weight: bold;">RECENT PUBLIC PRESENTATIONS</span><br /></p> <p>Please contact Patrick Burke at <a href="mailto:patrickb@amarexcro.com">patrickb@amarexcro.com</a> for handouts of these presentations.</p> <ul> <li>Opportunities in Developing Orphan Drug Products</li> <li>Regulatory Issues with Natural Products</li> <li>Adaptive Clinical Trials: Regulatory & Statistical Perspectives</li> <li>Preparing for an FDA Audit for GCP Compliance</li> <li>Changing Regulatory Environment in India for Clinical Trials, etc.</li> <li>Meeting the FDA</li> <li>Managing International Clinical Trials</li> <li>Building Productive Pipelines by Technology Transfer</li> <li>Do's and Don'ts of Outsourcing</li> <li>Electronic Submissions to the FDA</li> <li>FDA Acceptance of Foreign Clinical Trial Data</li> <li>Applicable Clinical Trials for Clinical Trial Registration</li> </ul> <p></p><p></p><p><a href="http://www.adobe.com/products/acrobat/readstep2.html"><img style="border: 0px solid ; width: 112px; height: 33px;" alt="Download Adobe Reader" src="../images/get_adobe_reader.gif" /></a></p> </div> </div> </div> <div class="footer-wrap"> <div class="footer"> <ul> <li>20201 Century Boulevard, Suite 450, Germantown, MD 20874</li> <li>301.528.7000</li> <li>866-Amarex1</li> <li class="last"><a href="http://www.amarexcro.com/" title="Amarex Website">www.amarexcro.com</a></li> </ul> </div> </div> </div> </body></html>