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brexit Archive | cunesoft.com

Prepare yourself for 2020 – Global regulatory update

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With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory world – we are aware of some changes that are coming along the way and we are certain that these will affect many of us. Therefore, it is crucial to be prepared for all the changes. We at Cunesoft believe in the importance of sharing knowledge and helping each other to prepare for upcoming regulations. Therefore we would like to share with you the summary of some important regulatory activities that are coming next year and beyond.

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The Challenge with EMA’s Changing Timelines for IDMP

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A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One factor is the pending relocation of EMA due to Brexit. Additional factors include the experience gained from implementation of RMS and OMS projects and the delivery method of the P&SMS project to engage the stakeholders. The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not  take place in 2018 and industry will not be requested to start submitting the product data in a new format in 2019. Read More