Arjun Guha Thakurta gave an overview on the current regulatory frameworks in the world and explained the regulations and laws in the US and the EU with regards to serialisation. He highlighted that pharma companies need to look at getting their serialisation systems in place as soon as possible to stay relevant in global markets and continue their growth trajectory. He shared details of the impact and implications of Falsified Medicines Directive and discussed strategies that would help pharma companies to deal with it. For instance, he elaborated on the packaging-tamper verification features for medicinal product packaging product that would be mandatory under the FMD.
Among other things, he also emphasised on the importance of data in ensuring future progress of the pharma companies and spoke on maintaining data repositories. He also stressed on how important it is to check and recheck all the data that goes out from a company to ensure data integrity. In his opinion, ensuring that the information is uploaded to the repositories system before the medicinal product is released for sale or distribution by the manufacturer and that it is kept up to date thereafter is an important quality attribute to consider. He pointed out that technology is ushering several revolutions in the life sciences industry. For instance, he expounded on the role of these technologies in acquiring, maintaining and applying data effectively in the pharma industry. He said that block chain can transform the pharma sector. It can help make data incorruptible if effectively implemented.
Thus, in his address he touched upon various aspects of serialisation and other issues that have growing relevance in the life sciences industry.
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