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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
Big Pharma's Organisational Development | Cristina Falcão | paradigm shift
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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
Cristina Falcão | obesity epidemic | obesity costs
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Big Pharma Cannot Afford to be Lost in Translation: Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. read more
Cristina Falcão
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Personalized Medicine –A Game with More Than One Nash Equilibrium: PM is no longer about the pharma industry alone – the players/stakeholders go far beyond the pharmaceutical and biotechnology industries, presenting a new challenge in assembling diverse technologies and partners working together. Success in this space will require new approaches, new relationships, and new ways of thinking. read more
personalized medicine | Cristina Falcão | personalised medicine
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Orphan Drugs – Reinventing Economies of Scale: The hardest area to improve is measurement and evaluation - pricing and reimbursement of orphan drugs are under payers’ scrutiny. read more
Cristina Falcão | orphan drugs | orphan drugs market
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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
orphan drugs | orphan drug market | personalised medicine
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Let’s All Do The Crowdsource And Clap Our Hands Together!: "I do believe Marsellus Wallace, my husband, your boss, told you to take ME out and do WHATEVER I WANTED. Now I wanna dance, I wanna win. I want that trophy, so dance good". Mia Wallace, Pulp Fiction (1994) Big Pharma never ceases to take prodigies out of the hat! read more
crowdsource | Cristina Falcão | crowdsourcing
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When Change Management is about Big Pharma Disruptive Changes ….: What were the odds that the drug makers would roll the dice and have not only a financial mega hit but in Mergers & Acquisitions and Offshore-Production two “star is born “stories in a single show? read more
Cristina Falcão | change management pharma | change management
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The Outsourcing Market – A Plethora of Choices: Globalisation’s growth and prevalence of the pharmaceutical market, calls for proactive approaches to manage its risks, namely the size and complexity of value chains and the increased labor market competition. = read more
Cristina Falcão | pharmaceutical outsourcing | outsourcing
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Change Control, You’d Better Have One!: While Change Control (CC) is applied to the entire chain of events in any pharma industry, from R&D to batch release, it is the core function of any pharmaceutical plant. “Even when a change is made to improve product or process quality, change control is required”. In a pharmaceutical plant, CC is the “champion” of all other processes; CC must be a centralised operation bearing no uncertainty over “whose job it is”. read more
Cristina Falcão | change control | pharmaceutical plant
| 12 column results |
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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 Charles
Global 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 Liscouski
Smooth 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 Madigan
6 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 Mookerjee
US 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 Harris
Biosimilars 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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