Most Marketing Authorisation Holders, as well as Contract Manufacturing Organisations, are starting to prepare for IDMP. A global compliance requirement that will become legally enforceable by the EMA from the middle of 2016 onwards.
During the summer period, the EMA IDMP Taskforce has given an insight to the approach they are proposing to the European Commission to follow. Although timelines are more realistic, the amount of effort involved, associated budgets required, and resources to plan for over the years to come, are still very substantial.
This presentation slides explore IDMP Readiness and address the following:
- Latest update on regulatory context for IDMP
- Real-time IDMP examples – the challenges our clients are facing
- IDMP readiness – what good looks like
- Where next?