January 8 2017
At the end of 2016, I attended the CBI 2nd Annual IDMP Update Forum in Philadelphia, a small but highly focused and effective conference with two days of meetings and discussions. There were presentations by industry leaders involved in understanding and addressing the challenges that IDMP compliance presents to the pharmaceutical industry, and also presentations by some of the vendors in this area.
The meeting kicked off with a keynote from John Kiser, Senior Director, Regulatory Policy and Intelligence, AbbVie. This brought up some of the key challenges for IDMP compliance that were repeated again and again across the conference:
- We need to think strategically, about master data management (MDM), not just about what is needed for IDMP compliance.
- Even though the timelines are moving out, it’s really important not to take our eye off the ball. IDMP projects are being driven out of EU, and the US has to get moving to keep up. Don’t wait, start planning and kicking off pilots and proof-of-concepts with vendors now.
- IDMP compliance planning shouldn’t just involve regulatory affairs and supply chain departments, as IDMP will impact quality, clinical operations, pharmacovigilance and safety, production, IT and more.
How text analytics using I2E can help
One comment that interested me was that while manual curation may provide the data elements for the current understanding of Iteration 1, other strategies will be needed to deal with potential changes in the implementation guidance, and to accommodate the flexibility required for Iteration 2 and beyond.