<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
	>

<channel>
	<title>ParagonRx Blog</title>
	<atom:link href="http://blog.paragonrx.com/feed/" rel="self" type="application/rss+xml" />
	<link>http://blog.paragonrx.com</link>
	<description>The latest in pharmaceutical appropriate use, risk management &#38; REMS</description>
	<lastBuildDate>Mon, 11 Apr 2011 20:28:04 +0000</lastBuildDate>
	<language>en</language>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=abc</generator>
		<item>
		<title>Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?</title>
		<link>http://blog.paragonrx.com/2011/04/11/complimentary-webinar-to-address-is-a-voluntary-rems-a-good-risk/</link>
		<comments>http://blog.paragonrx.com/2011/04/11/complimentary-webinar-to-address-is-a-voluntary-rems-a-good-risk/#comments</comments>
		<pubDate>Mon, 11 Apr 2011 20:28:04 +0000</pubDate>
		<dc:creator>Kevin Fetterman</dc:creator>
				<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[Webinar]]></category>
		<category><![CDATA[benefit-risk]]></category>
		<category><![CDATA[benefit-risk management]]></category>
		<category><![CDATA[REMS effectiveness]]></category>
		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>
		<category><![CDATA[risk mitigation]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=471</guid>
		<description><![CDATA[Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? These are the questions that will be addressed in a free webinar, “Voluntary Risk [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2011/04/11/complimentary-webinar-to-address-is-a-voluntary-rems-a-good-risk/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>ParagonRx Webinar to Provide Guidance On FDA Draft Guidance for MedGuides in REMS</title>
		<link>http://blog.paragonrx.com/2011/03/04/paragonrx-webinar-to-provide-guidance-on-fda-draft-guidance-for-medguides-in-rems/</link>
		<comments>http://blog.paragonrx.com/2011/03/04/paragonrx-webinar-to-provide-guidance-on-fda-draft-guidance-for-medguides-in-rems/#comments</comments>
		<pubDate>Fri, 04 Mar 2011 18:47:29 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[Tweets]]></category>
		<category><![CDATA[Webinar]]></category>
		<category><![CDATA[benefit-risk]]></category>
		<category><![CDATA[FDAAA]]></category>
		<category><![CDATA[medication guide]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[REMS design]]></category>
		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>
		<category><![CDATA[risk management]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=464</guid>
		<description><![CDATA[A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS). “Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2011/03/04/paragonrx-webinar-to-provide-guidance-on-fda-draft-guidance-for-medguides-in-rems/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>REMS 2010: A Year in Review</title>
		<link>http://blog.paragonrx.com/2010/12/03/rems-2010-a-year-in-review/</link>
		<comments>http://blog.paragonrx.com/2010/12/03/rems-2010-a-year-in-review/#comments</comments>
		<pubDate>Fri, 03 Dec 2010 17:37:53 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
				<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[Webinar]]></category>
		<category><![CDATA[approved REMS]]></category>
		<category><![CDATA[communication plan]]></category>
		<category><![CDATA[Elements to Assure Safe Use]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDAAA]]></category>
		<category><![CDATA[medication guide]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[REMS guidance]]></category>
		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>
		<category><![CDATA[webinar]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=459</guid>
		<description><![CDATA[As the pharmaceutical community looks forward to the issuance of the new FDA Risk Evaluation &#38; Mitigation Strategies (REMS) guidance in 2011, a free webinar will examine all the REMS occurrences during the past year and what they will portend for the future. This review of REMS in 2010 will be addressed in a webinar, [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/12/03/rems-2010-a-year-in-review/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>No Free Lunch:  An Intuitive Approach to Benefit-Risk Management</title>
		<link>http://blog.paragonrx.com/2010/11/16/no-free-lunch-an-intuitive-approach-to-benefit-risk-management/</link>
		<comments>http://blog.paragonrx.com/2010/11/16/no-free-lunch-an-intuitive-approach-to-benefit-risk-management/#comments</comments>
		<pubDate>Tue, 16 Nov 2010 16:41:25 +0000</pubDate>
		<dc:creator>Jeff Fetterman</dc:creator>
				<category><![CDATA[Appropriate Use]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[appropriate use]]></category>
		<category><![CDATA[benefit]]></category>
		<category><![CDATA[benefit-risk management]]></category>
		<category><![CDATA[drug safety]]></category>
		<category><![CDATA[Jeff Fetterman]]></category>
		<category><![CDATA[medication use]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[patient safety]]></category>
		<category><![CDATA[pharmaceutical]]></category>
		<category><![CDATA[risk]]></category>
		<category><![CDATA[safety]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=453</guid>
		<description><![CDATA[The pharmaceutical industry has become a favorite &#8220;bad guy&#8221; among the public, media, and legislators.  There is a perception that the many risks of medications is proof that the industry does not care about the safety of patients.  Nonsense.   Here are the facts: There is no benefit experienced by humans that is not gained [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/11/16/no-free-lunch-an-intuitive-approach-to-benefit-risk-management/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Pharmacovigilance, Benefit-Risk Roadmap Topic of the ParagonRx Wednesday Webinar</title>
		<link>http://blog.paragonrx.com/2010/11/09/pharmacovigilance-benefit-risk-roadmap-topic-of-the-paragonrx-wednesday-webinar/</link>
		<comments>http://blog.paragonrx.com/2010/11/09/pharmacovigilance-benefit-risk-roadmap-topic-of-the-paragonrx-wednesday-webinar/#comments</comments>
		<pubDate>Tue, 09 Nov 2010 19:07:42 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
				<category><![CDATA[REMS]]></category>
		<category><![CDATA[benefit-risk]]></category>
		<category><![CDATA[benefit-risk management]]></category>
		<category><![CDATA[drug safety]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[pharmacovigilance]]></category>
		<category><![CDATA[risk management]]></category>
		<category><![CDATA[risk management professionals]]></category>
		<category><![CDATA[safety]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=448</guid>
		<description><![CDATA[In response to the explosion of regulatory guidances, many pharmaceutical companies have established new processes and structure for pharmacovigilance and benefit-risk management.  However, the problem is that the training and competencies of those who have traditionally filled these roles may not be adequate to meet the new challenges. This issue of core competencies and who [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/11/09/pharmacovigilance-benefit-risk-roadmap-topic-of-the-paragonrx-wednesday-webinar/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Hot Topics in Assessing REMS Examined In ParagonRx October Wednesday FoREMS Webinar</title>
		<link>http://blog.paragonrx.com/2010/10/11/hot-topics-in-assessing-rems-examined-in-paragonrx-october-wednesday-forems-webinar/</link>
		<comments>http://blog.paragonrx.com/2010/10/11/hot-topics-in-assessing-rems-examined-in-paragonrx-october-wednesday-forems-webinar/#comments</comments>
		<pubDate>Mon, 11 Oct 2010 21:00:48 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
				<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[Tweets]]></category>
		<category><![CDATA[approved REMS]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[REMS effectiveness]]></category>
		<category><![CDATA[risk assessment]]></category>
		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=440</guid>
		<description><![CDATA[Of the 146 FDA REMS programs approved to date, 41 of them – almost one-third – have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessments. These topics will be the focus of a free webinar hosted by ParagonRx [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/10/11/hot-topics-in-assessing-rems-examined-in-paragonrx-october-wednesday-forems-webinar/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Computed Tomography (CT) Imaging Ethnography</title>
		<link>http://blog.paragonrx.com/2010/09/29/computed-tomography-ct-imaging-ethnography/</link>
		<comments>http://blog.paragonrx.com/2010/09/29/computed-tomography-ct-imaging-ethnography/#comments</comments>
		<pubDate>Wed, 29 Sep 2010 18:10:12 +0000</pubDate>
		<dc:creator>ParagonRx</dc:creator>
				<category><![CDATA[Appropriate Use]]></category>
		<category><![CDATA[General]]></category>
		<category><![CDATA[Tweets]]></category>
		<category><![CDATA[appropriate use]]></category>
		<category><![CDATA[ethnography]]></category>
		<category><![CDATA[medication use]]></category>
		<category><![CDATA[observational]]></category>
		<category><![CDATA[research]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=432</guid>
		<description><![CDATA[Computed Tomography (CT) diagnostic scans are performed on thousands of patients daily throughout the world.  CT scanning suites are under multiple pressures to optimize their process and improve their financial situations.  The diagnostic value of certain scans can be enhanced by the use of intravenous iodinated contrast agents (IVCA) as they allow for increased anatomical [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/09/29/computed-tomography-ct-imaging-ethnography/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Ethnographic Research and REMS</title>
		<link>http://blog.paragonrx.com/2010/07/12/ethnographic-research-and-rems/</link>
		<comments>http://blog.paragonrx.com/2010/07/12/ethnographic-research-and-rems/#comments</comments>
		<pubDate>Mon, 12 Jul 2010 22:12:33 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[REMS]]></category>
		<category><![CDATA[appropriate use]]></category>
		<category><![CDATA[approval]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[communication plan]]></category>
		<category><![CDATA[Drug]]></category>
		<category><![CDATA[ethnography]]></category>
		<category><![CDATA[medication]]></category>
		<category><![CDATA[medication guide]]></category>
		<category><![CDATA[observational]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[patient safety]]></category>
		<category><![CDATA[REMS implementation]]></category>
		<category><![CDATA[research]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=427</guid>
		<description><![CDATA[-Guest Blog by Andrea J. Simon, PhD.- In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/07/12/ethnographic-research-and-rems/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>REMS Assessments: Designing and Evaluating REMS</title>
		<link>http://blog.paragonrx.com/2010/05/26/rems-assessments-designing-and-evaluating-rems/</link>
		<comments>http://blog.paragonrx.com/2010/05/26/rems-assessments-designing-and-evaluating-rems/#comments</comments>
		<pubDate>Wed, 26 May 2010 18:55:06 +0000</pubDate>
		<dc:creator>Karen Lenoir</dc:creator>
				<category><![CDATA[Appropriate Use]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[FDA draft guidance]]></category>
		<category><![CDATA[ParagonRx]]></category>
		<category><![CDATA[patient safety]]></category>
		<category><![CDATA[REMS assessment]]></category>
		<category><![CDATA[REMS elements]]></category>
		<category><![CDATA[Risk Evaluation and Mitigation Strategy]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=424</guid>
		<description><![CDATA[Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments.  Assessments need to be designed in a way that measure risk mitigation.  Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings. REMS assessments should be designed in [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/05/26/rems-assessments-designing-and-evaluating-rems/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>REMS Assessments: Insights and Strategies for a Successful Survey Program</title>
		<link>http://blog.paragonrx.com/2010/05/12/rems-assessments-insights-and-strategies-for-a-successful-survey-program/</link>
		<comments>http://blog.paragonrx.com/2010/05/12/rems-assessments-insights-and-strategies-for-a-successful-survey-program/#comments</comments>
		<pubDate>Wed, 12 May 2010 19:30:24 +0000</pubDate>
		<dc:creator>Karen Lenoir</dc:creator>
				<category><![CDATA[Appropriate Use]]></category>
		<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[REMS]]></category>
		<category><![CDATA[communication plan]]></category>
		<category><![CDATA[Elements to Assure Safe Use]]></category>
		<category><![CDATA[guidance]]></category>
		<category><![CDATA[REMS assessment]]></category>
		<category><![CDATA[REMS effectiveness]]></category>
		<category><![CDATA[REMS elements]]></category>
		<category><![CDATA[REMS guidance]]></category>
		<category><![CDATA[risk assessment]]></category>

		<guid isPermaLink="false">http://blog.paragonrx.com/?p=417</guid>
		<description><![CDATA[REMS Assessments are now the hot topic in REMS.  We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications.  Companies need to begin to contemplate not just how to analyze and interpret their assessment findings, but they need to think about the best way to [...]]]></description>
		<wfw:commentRss>http://blog.paragonrx.com/2010/05/12/rems-assessments-insights-and-strategies-for-a-successful-survey-program/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
	</channel>
</rss>

