On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio Arias, Senior Consultant, IQVIA; Marieke Van Dalen, Global Regulatory Specialist, Aspen Oss B.V; Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs, Patheon, part of Thermo Fisher Scientific; Wei Tian, Director – Formulation, Lonza Capsugel; and Howard Sklamberg, Partner, Akin Gump.
Each panelist presented a few slides on their unique angle with regards to this issue, including how quality impacts the marketplace and downstream effects of quality lapses; international harmonization and challenges facing Chinese manufacturers; the role of CDMOs in collaborating with Chinese manufacturers to develop quality products; risk-based manufacturing; and a discussion of FDA priorities in regulation of drug quality.
These issues were of great interest to both the panel and the audience of representatives from pharmaceutical firms, and meaningful discussions occurred as a result. We enjoyed our role as moderator and participant in these discussions and look forward to more opportunities to do so!