Jakob Juul Rasmussen, IDMP Program Manager of Ferrings has been invited to present a case study at the “3rd Edition IDMP Compliance Challenge: Hit the phased approach deadlines” Conference in Frankfurt Germany.
The conference that is arranged by Marcus Evans will take place on 13th-15th of April in Frankfurt.
Jakob Juul Rasmussen will present examples of Iperion’s/Pharma IT’s “Full IDMP cycle approach” with specific data examples from SmPC’s and how the MedDRA coding process can be approached.
Iperion’s/Pharma IT full IDMP cycle approach supports:
- Awareness sessions
- Strategic implementation plan
- User requirements and specifications
- Snalysis and source system mapping and data pilot
- Collection of data from clinical and regulatory dossiers and documents
- Structured authoring of IDMP source documents to ensure alignment with IDMP controlled vocabularies
- Supporting and controlling MedDRA boding
- Updating your processes and instructions to accommodate continued IDMP compliance
Participating at this Marcus Evans’s conference will enable you to Benchmark with practitioners ahead of the curve:
- Manage effective compliance work and IDMP strategy despite missing EMA guidelines
- Preparing for 1st, 2nd and further iterations
- Organise actionable business preparation after impact assessment
- Find and draw together the missing data and build a smart data quality framework
- Lessons learnt and tip for software and vendor selection
- Hear the implementation plans in EU, US, Japan and other countries
- Submitting Investigative Products Data to EMA
- GINAS latest developments covered
More information can be found here.