The Year of Living Openly: Europe and Transparency 2015
The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes.
The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes.
The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
Improvement in the oversight of companies’ pharmacovigilance systems will also be a priority in the year ahead. Regulators have again taken steps aimed at improving patient safety - and, indeed, at encouraging patients to become more-active participants in their own health. And companies will have to determine how to respond to some of those developments.
Perhaps one of the paramount themes of the year - one that will only grow in the year ahead - is the narrowing gap between pharmacovigilance and regulatory.
All of those trends require pharmaceutical companies to improve their business processes and the ways they manage regulatory information across the enterprise.
To read the article by Dakshayini Kulkarni, click on the latest Pharm Exec Global Digest here.
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