PDA Announces Two U.S. FDA Center Directors for Opening and Closing Keynotes at the 2023 PDA/FDA Joint Regulatory Conference 19 July, 2023

PDA is pleased to announce that CDER Director Patrizia Cavazzoni, MD, and CBER’s Peter Marks, MD, PhD, will headline the opening and closing plenaries at the 2023 PDA/FDA Joint Regulatory Conference, in Washington, D.C., Sept. 18-20.

Dr. Cavazzoni will discuss maintaining quality assurance of medicines through sustainable compliance. Dr. Marks will address topics related to how the field uses scientific discovery and innovation to overcome pitfalls and consistently achieve robust quality for patients, deliver production efficiencies, and facilitate rapid patient access to safe and effective next-generation cell and gene therapies.

These sessions will bookend an information-packed agenda focused on important issues related to manufacturing and quality assurance. The conference will cover many pressing issues, including data integrity and innovation, CGMP training, and supply chain relationships and risk management.

Other representatives of the U.S FDA participating in the event are:

PANELISTS

• Paul Balcer, Program Manager, OMQ, OC, CDER
• Ashley Boam, MSBE, Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER (INVITED)
• Victor (Ray) Gaines, Branch Chief, OMQ, OC, CDER
• Marea Harmon, Consumer Safety Officer, OSC, CVM
• Brooke Higgins, MS, Acting Branch Chief, OC, CDER
• Lauren Howard, Drug Specialist and Pre-Approval Manager, OMPTO, ORA (INVITED)
• Laura Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, CVM
• Anthony Lorenzo, Branch Chief, OCBQ, CBER
• Kevin Maguire, Public Health Analyst, OMQ, OC, CDER
• J. Kevin Rice, PhD, CVM Pre-Approval Facilities Assessment Program, ONADE, CVM
• Obinna Ugwu-Oju, MS, Division Director, OPQ, CDER
• John Wan, MBA, Supervisor, OPQ, CDER
• Barbara Wilimczyk-Macri, Senior Compliance Officer, OMPTO, ORA (INVITED)

SPEAKERS

• CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
• Cindy Burnsteel, DVM, Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM
• Carol Cave, Deputy Associate Commissioner for Regulatory Affairs, ORA (INVITED)
• Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA (INVITED)
• Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER
• Tracey Forfa, JD, Director, CVM (INVITED)
• Jill Furman, JD, Director, Office of Compliance, CDER
• Milind Ganjawala, MS, MBA, Division Director, OC, CDER (INVITED)
• Francis Godwin, MBA, Office Director, OC, CDER
• Julianne McCullough, Senior Mutual Recognition Program Officer, OMPTO, ORA (INVITED)
• Melissa Mendoza, JD, Acting Director, Office of Compliance and Biologics Quality, CBER
• Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health, OCD, CDER
• Alex Viehmann, Division Director, OPQ, CDER
• Nicholas Violand, Investigator/Drug National Expert, OMPTO, ORA (INVITED)

Crowd-favorite sessions, including Center and Compliance Office Updates, Current CGMP Compliance Trends and Topics, and Lunch with the Regulators; plenty of networking opportunities; and a packed exhibit area combine to make this the manufacturing and quality assurance conference you cannot miss.

The exhibit area includes Silver Supporters Honeywell, Sparta Systems, and Lachman Consultants.

For more information, go to the conference website. Members of the press can request press passes here: https://www.pda.org/about-pda/press-pass-request-form.