Prepare yourself for 2020 – Global regulatory update

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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Regulatory Information Management - the Compliance & Efficiency Union

While the opinions about the information model for Regulatory Information Management vary and are subject to many ...

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Information on new Technical Rejection Criteria (FDA) on Study Data

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow ...

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How to achieve IDMP compliance

…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked ...

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Regulatory Master Data Management – Compliance, Technology and Science

Digital transformation is a hot topic. When applied to health products development, being able to combine science and ...

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Swiss eCTD Module 1 Specification updates

A revision of the Swiss eCTD Module 1 Specification documentation has been officially published by Swissmedic (link ...

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