Nanomedicines – Technical and Regulatory Perspectives
Nanomedicines are drug products that are formulated using colloidal systems, generally known as liposomes, nanospheres, microspheres, etc. This workshop is a forum for the discussion of the new challenges presented by this type of products including nomenclature, regulatory requirements, analytical techniques and procedures for the characterization and control of the critical quality attributes of these colloidal systems.
- Better understand the nomenclature of this type of drug products.
- Gain insight on the regulatory requirements for formulations containing colloidal systems.
- Discuss possible critical quality attributes for nanomedicines and the analytical techniques to monitor and control them.
- Nomenclature, Definitions, Regulatory Expectations (FDA, EMA, ASTM, ISO)
- Drug Release
- Analytical techniques for the characterization of colloidal systems
- Challenges in the formulation, manufacturing and stability of drug products containing colloidal systems
Who Should Participate?
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
- Ecevit Bilgili, Associate Professor of Chemical Engineering, New Jersey Institute of Technology
- Susanne Bremer-Hoffman, Senior Scientific Officer, European Commission
- Daan Crommelin, Emeritus Professor in Biopharmaceutics, Utrecht University
- Amber Fradkin, Associate Director, KBI Biopharma, Inc.
- Martin Fritts, National Institute of Standards and Technology/NCI
- Alexis Guillot, Scientist, PHAST GmbH
- Anthony Hickey, Distinguished Fellow, Aerosol and Nanomaterials Engineering, RTI International
- Mario Hubert, Principal Scientist, Bristol-Myers Squibb
- Fred Klaessig, Manager, Pennsylvania Bio Nano Systems, LLC
- Andrew Latham, Merck Research Laboratories
- Tao Lu Lowe, Associate Professor, Biomedical Engineering, University of Tennessee Health Science Center
- Margareth Marques, Principal Scientific Liaison, USP
- Scott McNeil, Director, Nanotechnology Characterization Laboratory, National Cancer Institute/NIH
- Ajit Narang, Senior Scientist, SMPS, Genentech, Inc.
- Don Parsons, Vice President, Pharmaceutical Development, BIND Therapeutics
- Alan Rawle, Applications Manager, Malvern Instruments
- Christie Sayes, Associate Professor of Environmental Science, Baylor University
- Rene Thuermer, BfArM, Federal Institute for Drugs and Medical Devices, Germany
- Donald Tomalia, CEO/Founder, NanoSynthons, LLC
- Katherine Tyner, Center for Drug Evaluation and Research, U.S. Food & Drug Administration
- Matthias G. Wacker, Head of Department, Pharmaceutical Technology and Nanosciences, Fraunhofer-Institute, Germany
- Sylvia Wagner, Head of Department, Fraunhofer-Institut fur Biomedizinische Technik
- Jingtao Zhang, Principal Scientist, Merck
- Ye Zhang, Staff Fellow, U.S. Food & Drug Administration
Advance Registration Deadline: March 17, 2017. After that date, you may register on-site at the USP Meetings Center.
Regular Fee Per Person
(1-2 individuals from the same organization)
Early Bird Discount
(Register by December 31, 2016)
(3 or more individuals from the same organization; all must register at the same time to receive the discount)
Cancellation and Substitution Policy
Invitation Letters for Visas
Local Area Information
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