DADI: An Upcoming Regulatory Business Transformation Project from the EMA

In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form called the Digital Application Dataset Integration (DADI). The European Medicines Agency (EMA) designed DADI as a long-term replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.

Methodologies Effecting the IDMP Implementation: Pick the Right Solution

IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency)  would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources. The methodologies followed by companies decide the success or failure of the implementation.