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Wednesday, February 6 • 15:15 - 16:45
#SP01: Nanomedicines and Nanosimilars – Implications for Regulators, Payers and Prescribers

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Component Type: Session

Nanomedicines have been gaining increasing attention in academia and research and over the past twenty years due to the potential they can offer in opening up new or improved therapeutic opportunities. Nanomedicines are however highly complex. Due to their size, they different from small molecules as their properties cannot be fully characterised and minor changes in manufacturing can affect size and/or morphology influencing their quality, biological properties and therapeutic profiles. In the absence of a specific regulatory pathway and legal definition, this workshop will discuss the appropriateness of the current regulatory approval process for nanomedicines and their follow-on products and analyse the potential implications for regulators, payers, physicians and ultimately patients. **This is an invitation-only workshop sponsored by Vifor. For further information please contact DIA.


Hubert G. M. Leufkens, PharmD


Regulatory Considerations for the Approval of Nanomedicines and Nanosimilars Regulatrory Considerations for the Approval of Nanomedicines and Nanosimilars
Beatriz Silva Lima, PharmD, PhD

Clinical Perspective of the Potential Implications of Nanosimilars What are Nanomedicines and How Do They Differ from ‘Traditional’ Small Molecules?
Gerrit Borchard

avatar for Hubert Leufkens

Hubert Leufkens

Professor, Pharmaceutical Policy and Regulatory Science, Utrecht University
Hubert (Bert) G. Leufkens is professor of Pharmaceutical Policy and Regulatory Science at Utrecht University. He is research and policy-wise active at several (inter)national platforms on innovation, drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmacovigilance... Read More →
avatar for Beatriz Silva Lima

Beatriz Silva Lima

Professor of Pharmacology; NDA Advisory Board, NDA Advisory Services Limited
i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy... Read More →
avatar for Gerrit Borchard

Gerrit Borchard

University of Geneva
Gerrit Borchard is a licensed pharmacist and obtained his Ph.D. in pharmaceutical technology from the University of Frankfurt. After holding several academic posts at Saarland University (DE) and at Leiden University (NLD), he joined Enzon Pharmaceuticals, Inc. (USA) as Vice President... Read More →

Wednesday February 6, 2019 15:15 - 16:45 CET
0.11-0.12 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria