ISO In Revision of IDMP Standards - What Should You Know?

As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information. The standards (ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844) help simplify the exchange of medicinal product information and aid promotion of safer patient care, by helping regulators to interoperate with each other.

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.

XEVMPD: How a Partner Helps Efficiently Navigate the Submissions Landscape

The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now.  EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.