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	<title>Drug Development Consultant and Regulatory Consultant</title>
	<link>http://www.damienbove.com</link>
	<description>Damien Bove Shares The Expertise</description>
	<lastBuildDate>Tue, 09 Mar 2010 08:02:01 +0000</lastBuildDate>
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		<title>Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases</title>
		<description><![CDATA[The, FDA, are providing manufacturers of viral vaccines, with guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use]]></description>
		<link>http://www.damienbove.com/2010/03/09/drug-regulators-fda-publish-guidance-on-characterisation-and-qualification-of-cell-substances-and-other-biological-materials-used-in-the-production-of-viral-vaccines-for-infectious-diseases/</link>
			</item>
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		<title>Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence</title>
		<description><![CDATA[Alcohol dependence is in general accepted as a psychiatric disorder with harmful physical, mental and social consequences and a high probability of a chronic relapsing course. It is considered a major public health problem in most Western societies. The aim of this guideline is to provide guidance on clinical studies for drugs developed for the treatment of alcohol dependence.]]></description>
		<link>http://www.damienbove.com/2010/03/08/drug-regulators-ema-emeapublish-guidance-on-the-development-of-medicinal-products-for-the-treatment-of-alcohol-dependence/</link>
			</item>
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		<title>Twitter Weekly Updates for 2010-03-07</title>
		<description><![CDATA[
Some projects require a huge amount of work to develop a scope! This requires a professional and flexable approach! #
Contemplation is as powerful as action! However like all powerful flavours it needs to be used in careful moderation! #
When you biomarker is a hormone or steroid you realy need to understand its circadian rhythm, measuring [...]]]></description>
		<link>http://www.damienbove.com/2010/03/07/twitter-weekly-updates-for-2010-03-07/</link>
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		<title>Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices &#8211; Cardiac Ablation Catheters</title>
		<description><![CDATA[This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices Vigilance System]]></description>
		<link>http://www.damienbove.com/2010/03/06/device-regulators-mhra-publish-draft-for-comment-on-vigilance-systems-for-ce-marked-medical-devices-cardiac-ablation-catheters/</link>
			</item>
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		<title>Drug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.</title>
		<description><![CDATA[This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs.]]></description>
		<link>http://www.damienbove.com/2010/03/04/drug-regulators-fda-publish-draft-guidance-on-adaptive-design-clinical-trials-for-drugs-and-biologicals/</link>
			</item>
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		<title>Drug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes</title>
		<description><![CDATA[This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.]]></description>
		<link>http://www.damienbove.com/2010/03/03/drug-regulators-fda-publish-guidance-on-submission-of-documentation-in-applications-for-parametric-release-of-human-and-veterinary-drug-products-terminally-sterilized-by-moist-heat-processes/</link>
			</item>
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		<title>Drug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials</title>
		<description><![CDATA[This guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with our interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic.]]></description>
		<link>http://www.damienbove.com/2010/03/02/drug-regulators-fda-publish-draft-guidance-for-industry-non-inferiority-clinical-trials/</link>
			</item>
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		<title>Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence</title>
		<description><![CDATA[Organisations that commented on the draft Guideline as released for consultation]]></description>
		<link>http://www.damienbove.com/2010/03/01/drug-regulators-emea-ema-publish-comments-draft-guidance-on-the-investigation-of-bioequivalence/</link>
			</item>
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		<title>Drug Regulators, MHRA, Publish Best Practice Guidance on the Same of Pain Relief</title>
		<description><![CDATA[Medicines for pain relief on general sale are effective and acceptably safe when used according to the label instructions. But there is evidence to show that people sometimes use large quantities of these medicines impulsively]]></description>
		<link>http://www.damienbove.com/2010/03/01/drug-regulators-mhra-publish-best-practice-guidance-on-the-same-of-pain-relief/</link>
			</item>
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		<title>Twitter Weekly Updates for 2010-02-28</title>
		<description><![CDATA[
A comprahensive training package for those involved in healthcare technology commercialisation will be launched soon watch this space #
When thinking about medical devices marketing is so much more important than with drugs! Route to market needs to be in you development plan #
New business support website to be launched soon! Helping consultants profit maximise! #

Powered [...]]]></description>
		<link>http://www.damienbove.com/2010/02/28/twitter-weekly-updates-for-2010-02-28/</link>
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