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Regulatory Science Forum

Session 3: Nanosimilars

Session Chair(s)

Jon S De Vlieger, PhD

Jon S De Vlieger, PhD

  • Coordinator NBCD Working Group and Director Business Development
  • Lygature, Netherlands
Session 3: Nanosimilars


Susanne  Bremer-Hoffmann

Identification of regulatory needs for nanomedicines

Susanne Bremer-Hoffmann

  • Joint Research Centre (JRC)
  • European Commission, Italy
Kevin  Klein, PhD, MSc

The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations

Kevin Klein, PhD, MSc

  • Program Manager
  • Lygature, Netherlands
Falk  Ehmann, MD, PhD, MS

EMA’s approach to the Evaluation of Medicines containing Nanotechnology

Falk Ehmann, MD, PhD, MS

  • Chair of Innovation Task Force
  • European Medicines Agency, Netherlands

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