By now pharmaceutical industry is quite familiar and compliant with EVMPD. The next step, IDMP standards have been published by the ISO in November 2012. The next big challenge is to ensure that while maintaining full EVMPD compliance, companies need to prepare their systems and gather required data to ensure compliance with upcoming regulations around IDMP.
Although most companies have established that their Regulatory Affairs departments own relevant databases and regulatory compliance it is also clear that the level of information which is defined in the IDMP standard has to come from different departments within the organization. Compliance with IDMP standards is not the task of only the Regulatory Affairs department but also of the entire organization. Companies will need to put databases, interfaces as well as business processes in place to ensure that all of the information is provided accurately on time to the Regulatory Affairs department so that it can be compiled and submitted to the regulators such as EMA or USFDA etc. IDMP is more than just ensuring collection and submission of product information. There is the need for the use of this information by the safety department while submitting complaint ICSR files to the regulator(s).
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