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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
European Commission, Italy
Joint Research Centre (JRC)
The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations
Kevin Klein, PhD, MSc
Lygature, Netherlands
Program Manager
EMA’s approach to the Evaluation of Medicines containing Nanotechnology
Falk Ehmann, MD, PhD, MS
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Head of Innovation and Development Accelerator – ad interim,
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