Nanomedicines: Technical and Regulatory Perspectives Workshop
March 20-22, 2017 | USP Meetings Center | Rockville, Maryland, USA
Presented in partnership with:
About This Workshop
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.
Areas of Discussion
- 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
- Susanne Bremer-Hoffman, Senior Scientific Officer, European Commission
- Daan Crommelin, Emeritus Professor in Biopharmaceutics, Utrecht University
- Martin Fritts, National Institute of Standards and Technology/NCI
- Anthony Hickey, Chief Executive Officer & President, Cirrus Pharmaceuticals
- Mario Hubert, Principal Scientist, Bristol-Myers Squibb
- Margareth Marques, Principal Scientific Liaison, USP
- Don Parsons, Vice President, Pharmaceutical Development, BIND Therapeutics
- Christie Sayes, Associate Professor of Environmental Science, Baylor University
- Katherine Tyner, Center for Drug Evaluation and Research, U.S. Food & Drug Administration
- Ye Zhang, Staff Fellow, U.S. Food & Drug Administration