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Next Generation Nanomedicines and Nanosimilars: Regulators’ Perspective
Session Chair(s)
Suzanne Sensabaugh, MBA, MS
President and Principal Consultant
HartmannWillner LLC, United States
Recent advances in nanoscience are bringing novel opportunities to master matter at a nano-scale size, leading to the creation of even more complex, hybrid structures by both new top-down fabrication and bottom-up manufacturing techniques. This is paving the way for a wave of new pharmaceuticals, imaging agents and combination products – so called “next generation” nanomedicines. Given the degree of complexity of these products, a need to adapt current regulatory scientific requirements has been noted. In this session, we will address recent regulatory activities such as an international collaboration on guidance development of nanomedicines and nanosimilars, as well as examine regulatory strategies and harmonization in nanomedicines, particularly in the Asia Pacific region.
Learning Objective : Discuss the specific characteristics of nanomedicines including their development and evaluation; Describe the concept of nanosimilars (follow-on nanomedicines); Discuss nanosimilars and second generation nanomedicines current regulatory thinking and requirements for their development and assessment; Explain the direction and strategies to reach regulation harmonization and convergence.
Speaker(s)
The Regulatory Convergence Challenge for Nanomedicines
Jo-Feng Chi, PhD
TFDA, Chinese Taipei, Taiwan
Deputy Director of Medicinal Products
The Next Generation of Nanomedicine: FDA/CDER Perspective
Katherine Tyner, PhD
FDA, United States
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
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