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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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Health informatics – IDMP – Implementation guidelines for ISO 11238

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While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background. The latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”. Read More

eCTD Health Canada – an overview

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eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada. Read More