Regulatory Intelligence SPIN

The framework for the regulation of medicines grows more complex every day. The development of new product types, the harmonisation of requirements and the addition of new countries to the EU all have resulted in an environment where it’s becoming increasingly hard to predict how the regulatory agencies will view applications.

At the same time we see more and more information becoming available.
The drive for greater transparency is ensuring that this trend continues to accelerate. Consequently it is important to know how to find this information, filter it and analyse it in ways that can increase our understanding of expectations of the regulatory agencies.

As a result of these changes, the discipline of regulatory intelligence is becoming increasingly important to more accurately predict and manage the expectations of regulatory agencies at both the national and international level.

Much interest has already been shown in the formation of a SPIN that will focus on the subject of Regulatory Intelligence. The aim of this group will be to explore and share ideas and methods used for regulatory intelligence, and will be open to all TOPRA members from companies of all sizes. This new SPIN will be launched on Tuesday 23 February at a face-to-face meeting which will be held at TOPRA’s offices in London. If you are interested in the group and would like to attend the launch, or know more, please send an E-mail to spin@topra.org.

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