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Regulatory Science Forum
Session 3: Nanosimilars
Session Chair(s)
Jon S De Vlieger, PhD
- Coordinator NBCD Working Group and Director Business Development
- Lygature, Netherlands
Session 3: Nanosimilars
Speaker(s)
Identification of regulatory needs for nanomedicines
Susanne Bremer-Hoffmann
- Joint Research Centre (JRC)
- European Commission, Italy
The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations
Kevin Klein, PhD, MSc
- Program Manager
- Lygature, Netherlands
EMA’s approach to the Evaluation of Medicines containing Nanotechnology
Falk Ehmann, MD, PhD, MS
- Chair of Innovation Task Force
- European Medicines Agency, Netherlands
