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Orphan Drugs are Forerunners of Personalised Medicine: Marketing exclusivity in EU and U.S.A provided a monopolistic market for orphan drugs without “me-too”/generics competitors, to pharma companies.| Orphan drug laws and the pharma industry made great contributions towards the cure of millions of people offering from uncommon and frequently life-threatening diseases. However, it is necessary to strike a new balance between incentives and competition. read more
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Hey Big Pharma, Hey Big Spender! Steps to Improve Pharma R&D ROI: In times of global recession pharma industry was not immune to the direct and indirect effects of the economic crisis. It is not just about dry pipelines and skyrocketing R&D costs; it is also about the profound changes in global healthcare systems. read more
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A Revolutionary Paradigm Shift in Big Pharma's Organisational Development: A paradigm is the conceptual framework upon which we build our world; it is built upon past experiences; if we are not willing to make shifts in our paradigms, we will remain stagnate in our growth; a paradigm shift is a change from one way of thinking to another; it is something that does not happen like self generation it is driven by change. read more
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Taxing “Globesity” To Save Our Children: Will “Fat taxes” affect consumption, and eventually obesity? The impact of imposing taxes on the consumption of certain foods depends on the responsiveness of consumers to price changes, i.e. price elasticity. It is difficult to predict how consumers will react to price changes caused by taxation. read more
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Patent Drafting and Claim Construction: To determine whether the patentee has right to exclude for a particular claimed invention, it is essential to know what is claimed and this process is called determining the scope of the invention or claims construction. read more
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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
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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
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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
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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
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
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