Technical and Regulatory Perspectives

Co-sponsored by: International Pharmaceutical Federation (FIP) and American Association of Pharmaceutical Scientists (AAPS)

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.

Agenda E-Program Register

Why Attend?

  • 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.

Discussion Areas

  • 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.

NOTE: registering for a USP event requires an Access Point account. if you do not have an Access Point account, follow the instructions after clicking the ‘REGISTER’ button.


Registration is only payable by credit card.

Participant Type Regular Fee Per Person
(1-2 individuals from the same organization)
Early Bird Discount
(Register by December 31, 2016)
Multi-Registrant Price
(3 or more individuals from the same organization; all must register at the same time to receive the discount)
Academia Participant $600 $550 $500
Association Participant $600 $550 $500
Government Participant $275 N/A N/A
Industry Participant $800 $750 $700
Student Participant $275 N/A N/A

Registering Others

When registering colleagues, create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, select “add additional registrants” on the final page of the registration form (before submitting payment).

Cancellation and Substitution Policy

Cancellation must be received on or before February 27, 2017. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations. You may send a substitute registrant from your same organization. Substitutions must be submitted via email. To cancel or substitute your registration, contact

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees. Once registered USP will provide a registration confirmation that may be utilized to obtain a visa. Request this confirmation by contacting


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