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Pharmacoepidemiology and Pharmacovigilance: As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug. read more
Elie Magdalani | pharmacoepidemiology | pharmacovigilance
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Medication Errors - A Shared Responsibility: We can not separate pharmacovigilance from medication errors, pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors. Pharmacovigilance contributes to the detection and prevention of medication errors, collaboration of all parties will improve the quality of data collected, and enhancing patient safety. A shared responsibility, in detecting Medication Errors depends on the collaboration of the patient, the pharmaceutical companies, the pharmacovigilance centers, and poison control centers. read more
Elie Magdalani | Ranbaxy Egypt | medication errors
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Global Drug Safety and Risk Management: The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response. read more
Elie Magdalani | Ranbaxy Egypt | pharmacovigilance
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Patients Safety and Clinical Trials: Emerging new safety data may result in an action plan by the pharmaceutical company producing a drug to review its data retrieved during the clinical trail phases and especially in Phase II conducted to demonstrate and assess the product’s safety. read more
Elie Magdalani | Ranbaxy Egypt | pharmacovigilance
Events of Interest
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Global Pharmaceutical Distribution 2012
Venue to be Confirmed, Amsterdam, The Netherlands
September 18- 19, 2012 -
Cool Chain Logistics 2013
Congress Center Basel, Basel, Switzerland
January 28- 30, 2013 -
Information Governance & eDiscovery for Pharma, Biotech and Medical Devices
London, UK
June 26- 28, 2012 -
Cold Chain Global Forum 2012
Chicago, IL
September 24- 28, 2012
Articles
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Contributor: Andrea CharlesGlobal Clinical Outsourcing Forum – Avoids Death by PowerPoint with New Format – Round Up: GCOF took brave step this year and was un-conferenced. The 3rd Annual Global Cli... read more
Tags: clinical outsourcing | global clinical outsourcing | Global Clinical Outsourcing Forum
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Contributor: Joe LiscouskiSmooth the Path to Integration in Informatics: With an increasing emphasis on informatics and the potential to better organize and manage... read more
Tags: Informatics | Standards | integration
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Contributor: Niamh Madigan6 Tips to Achieving the Impossible in the Face of Change: Let’s face it, we live in a world that is constantly changing and nowhere ... read more
Tags: change | impossible | possible
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Contributor: Runa MookerjeeUS Healthcare Regulation, Technology Advancements Spell Boom for Outsourcing: Advancements in healthcare technology, apart from improvement of quality of care, are almo... read more
Tags: electronic medical record | EMR | electronic health record
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Contributor: James HarrisBiosimilars Landscape and FDA Regulatory Expectations: The Congressional Budget Office (CBO) has estimated that the United States could save $25 ... read more
Tags: biosimilars | FDA | FDA regulatory expectations





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