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2021 APAC Pharmaceutical Manufacturing Conference and Global Regulatory Summit

VL21CEJUN1/SES106 - Regulatory and Industry Panel

Jun 18, 2021 6:15am ‐ Jun 18, 2021 7:30am


Regulatory and Industry Panel | Maintaining Full Transparency with Regulatory Agencies

Session Leader(s):

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


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



  • David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA
  • 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, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
  • José E. Meléndez, Consumer Safety Officer, FDA/ORA
  • Kevin O'Donnell, PhD, Market Compliance Mgr & Sr Inspector, 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

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