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First UNICOM transatlantic meeting
June 8, 2021 @ 3:00 pm - 5:00 pm
The meeting will update US key decision makers on the objectives and current achievements of UNCIOM and will open the way to to wider and more focused discussions on alignement possibilities.
The EU UNICOM Trans-Atlantic Stakeholders Webinar will be officially coordinated by *CTADHL, a UNICOM partner formally tasked for trans-Atlantic outreach by UNICOM to include promotion and adoption of ISO IDMP across the medicinal product lifecycle. Although UNICOM is an EU initiative, it strongly considers collaboration and exchange with North American stakeholders as part of its remit to actively promote a common vision for IDMP and other relevant data standards adoption on an international scale.
We have planned the following agenda:
- Welcome, introduction to CTADHL and UNICOM (Vada Perkins, Frits Stulp and Christian Hay)
- Opening remarks (US FDA speaker-TBD)
- US FDA perspective: current activities (Ron Fitzmartin – TJ Chen-US Food and Drug Administration)
- EMA perspective: SPOR (Isabel Chicharo – European Medicines Agency)
- The global perspective (Malin Fladvad – WHO-Uppsala Monitoring Centre)
- Impact on international standards (Mike Glickman, Christian Hay – ISO)
- Closing remarks (Stan van Belkum – Central Committee on Research Involving Human Subjects)