How to Protect Your IP Rights Abroad

Jul 19, 2016

Many life sciences companies which protect their inventions, brands or product designs through patents, trademarks or registered designs in their home country, do not realise that this does not give them automatic protection in other countries. Intellectual property rights are territorial rights, meaning that the protection afforded by a granted patent or a registered trade mark is geographically limited. Jim Robertson at Wynne-Jones IP submits his white paper on IP rights abroad. ...

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Why Agility Holds the Key to Transformation in Life Sciences

Jul 19, 2016

The priority that will unite all life sciences companies in 2016 is the pursuit of greater agility. As long as organisations keep taking a short-term view, investing in standalone information management systems for each new business requirement, the only thing they’ll successfully grow is cost, warns Mark Evenepoel, Group CEO at Amplexor Life Sciences. The real focus should be flexibility and responsiveness to whatever the market demands next. ...

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The Total IDMP Effort – an insight into the data volume of an ISO IDMP submission

Jul 19, 2016

It has, since 2012, been a well-established fact that pharmaceutical companies which have medicinal products or are conducting clinical trials in the European Union (EU) will have to adhere to the ISO standards mandated in EU Regulation 520/2012. With the aim of improving overall pharmacovigilance signal detection and oversight, the European Medicines Agency (EMA) will rely on these standards (11615, 11616, 11238, 11239 & 11240) to achieve this goal. Niels Grønning and Rune Ringsholm Bergendorff at NNIT give us an insight into the data volume of an ISO IDMP submission. ...

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Exploring the Opportunities and Challenges in Repurposing a Master Dossier

Jul 19, 2016

It is known that developing an innovative healthcare product from bench to market is a very expensive and complex effort, as the pharmaceutical industry is highly regulated to protect the consumer. Global spend on medicines is forecast to reach nearly $1.4 trillion by 2020, an increase of about 32% over 2015. This is driven by population growth and improved access to emerging markets. Interestingly, the revenue driver at many leading companies remains the innovative medicines portfolio, despite some companies diversifying into generics, consumer medicines, diagnostics and other related healthcare products. Bindu Narang, Director of Scientific Writing Regulatory Affairs, with Dr ...

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