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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
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
Head of Innovation and Development Accelerator, Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
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