We all know the legislative deadline for submitting pharmacovigilance data as IDMP (Identification of Medicinal Products), is July 1st of 2016. We only have several months time to become IDMP ready and prepare for the submission of medicinal product information. xEVMPD (Extended Eudravigilance Medicinal Product Dictionary), the current legislative format, was simple and easy to compile compared to the large and complex data structures for IDMP. Most of you have probably read the five relevant ISO IDMP guidelines ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11 240. They provide all necessary details on required data, but also we all know that these ISO guidelines will be followed by EMA and NCA implementation guidelines (later this year?) that will describe what exactly we will have to submit on July 1st 2016.
Topics covered within this webinar:
1. IDMP – Status Quo
2. How to prepare for IDMp
2.1 Data source analysis (Excel based)
2.2 Data gathering (Software based)
2.3 IDMP ramp up program options
3. Why IDMP can drive innovation