How ready are you for IDMP?
IDMP (IDentification of Medicinal Products) is a set of international standards developed by ISO that will become mandatory in Europe in a phased approach, effective from 2018, and will also be adopted by the FDA and globally over the next few years. As with any new regulatory change, it is valuable to hear about others' experiences and ideally understand and learn from industry best practice.
Joining the IRISS Forum is the best way of keeping track of IDMP. I joined IRISS this year - it is an excellent source for up-to-date IDMP information and also valuable input from industry experts (such as Andrew Marr, Vada Perkins, and others).
The IRISS (Implementation of Regulatory Information Submission Standards) Forum was created to address the need for a single central forum for open and broad stakeholder discussion of evolving standards, user requirements and practical, global implementation issues of these standards for the mutual benefit of both industry, government agencies and ultimately, public health.
IRISS recently (September 2016) surveyed its members, both pharmaceutical and vendor, across the current state of readiness around IDMP compliance. The companies that took part in the industry survey covered a wide range of organizational sizes, from small companies those with less than 100 EU authorizations to larger ones with more than 5000 (or, less than 10 active ingredients to more than 250). Over 80% of those in the survey had a global reach.