VL21CEJUN1/SES106 - Regulatory and Industry Panel

Session Leader(s):

• Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Panelist(s):

• Jila Breeze, EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.

Speaker(s):

• Davide Buratti, GxP Compliance Operations Director - Partner, PQE Group

Panelist(s):

• David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics
• V. R. Gaines, Branch Chief, Division of Drug Quality I, FDA
• R. Derek Glover, Head of Global Quality, Viatris
• Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
• Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER
• José E. Meléndez, Consumer Safety Officer, FDA/ORA
• Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority (HPRA)
• Ranjana B. Pathak, DHA, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.
• Aditi S. Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF
• Frances M. Zipp, President & CEO, Lachman Consultant Services