The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies

Apr 28, 2012

The European Medicines Agency (EMA) recently announced new pharmacovigilance legislation, more commonly known as “the pharmaceutical package”. In this package the EMA describes how to modernise its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Olaf Schoepke and Gerhard Neurauter at EXTEDO explain how agencies and pharmaceutical companies can address this new legislation, along with the respective consequences for their data management. ...

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United Nations Summit on Non-communicable Diseases

Apr 28, 2012

The NCD epidemic is hitting vulnerable, socially and economically disadvantaged people the hardest. The World Economic Forum’s 2010 Global Risk Report lists NCDs as the second-greatest risk to global economic growth. One half of those who die from NCDs are in their productive years, making the social costs and economic consequences in terms of lost productivity considerable. Rebecca MORTON DOHERTY of Union for International Cancer Control (UICC) discusses that, by having the UN Summit and agreement on a political declaration on NCDs, the process of addressing NCDs globally has been set in motion in the most powerful way. ...

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Personalised Medicine & Companion Diagnostic Device Development

Apr 28, 2012

Healthcare in the developed world is on the edge of a precipice. Populations are aging and healthcare costs are rising against the backdrop of uncertain economic times. Consulting the latest OECD figures shows the cost of healthcare as a percentage of GDP rising from 13.6% to 17.4%. Nick Rollings of Sagentia explores how the pharma industry itself is undergoing a period of intense change. ...

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The Future of Franco-British Trade Relations

Apr 28, 2012

The UK-French Trade Commission UBIFRANCE assists French companies with their development in the British market for an extensive range of sectors. IPI speaks with Katie Docwra of UBIFRANCE about the future in Franco-British trade relations. ...

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Moving to a Common Interpretation of eSubmission Validation Criteria?

Apr 28, 2012

2011 has been an interesting year for those using the ICH eCTD standard. Several agencies or groups of agencies have made changes related to their use of eCTD. The US FDA released new validation rules late in 2010 and now plans to implement them later this year. Health Canada has announced that it intends to release a new version of its Module 1 this year. In this article Charles Mathis of the LORENZ Life Sciences Group focuses on changes which have already been implemented by the European Agencies, with the implementation of new validation criteria. ...

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