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  5. Public Calendar: June 4-10, 2023
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: June 4-10, 2023

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Robert M. Califf, M.D., MACC, Commissioner for Food and Drugs

Event Date: 06/05/2023
Location: Virtual
Subject: Supply Chain Resiliency
FDA Participant/Group: JULIA TIERNEY; MICHELLE ADAMS; ANDREW ZACHER;
Non FDA Participant/Group: Chris Fetzer (Dentons Law Firm); Patrick Cashman (USAntibiotics LLC);

Event Date: 06/05/2023
Location: Virtual
Subject: Supply Chain Resiliency
FDA Participant/Group: JULIA TIERNEY; ANDREW ZACHER; MICHELLE ADAMS;
Non FDA Participant/Group: Christine Baeder, Michael Brzica, Sven Dethlefs (Teva Pharmaceutical Industries);

Event Date: 06/05/2023
Location: Virtual
Subject: Supply Chain Resiliency
FDA Participant/Group: MICHELLE ADAMS; HILARY MARSTON; ANDREW ZACHER; JULIA TIERNEY;
Non FDA Participant/Group: Heather Zenk, Robert Mauch, Steve Collis (AmerisourceBergen);

Event Date: 06/05/2023
Location: Virtual
Subject: FDA Small Business and Industry Regulatory Education for Industry Annual Conference
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 06/07/2023
Location: Boston, MA
Subject: Biotechnology Innovation Organization (BIO) International Convention; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, media, and other registered attendees

Event Date: 06/08/2023
Location: Virtual
Subject: FDA's Online Controlled Substances Summit
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, and other invited attendees

Event Date: 06/09/2023
Location: Virtual
Subject: Supply Chain Resiliency
FDA Participant/Group: HILARY MARSTON; ANDREW ZACHER; MICHELLE ADAMS; JULIA TIERNEY;
Non FDA Participant/Group: Chris Alverson, Gene Cavacini, Pete Slone, Robert Schrepfer (McKesson);

Official Name: Janet Woodcock, M.D., Principal Deputy Commissioner

No Significant Event

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

Event Date: 06/09/2023
Location: Virtual
Subject: Collaboration Opportunities
FDA Participant/Group: N/A
Non FDA Participant/Group: Suja K. Menon (Indian Ministry of Commerce and Education);

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Namandjé N. Bumpus, Ph.D., Chief Scientist

Event Date: 06/06/2023
Location: Virtual
Subject: Centers of Excellence in Regulatory Science and Innovation (CERSI) Network Quarterly Meeting; Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of Yale University, Duke University, University of Maryland, and Johns Hopkins University

Event Date: 06/07/2023
Location: Washington, DC
Subject: Introductory Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Representative Bruce Westerman (R-AR)

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 06/06/2023
Location: Virtual
Subject: Biotechnology Industry Organization (BIO) International Convention 2023; Panelist: FDA Town Hall Panel
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 06/07/2023
Location: Virtual
Subject: International Coalition of Medicines Regulatory Authorities (ICRMA) Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives of the International Coalition of Medicines Regulatory Authorities member countries

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 06/05/2023
Location: Washington, DC
Subject: HHS and American Society of Hematology Sickle Cell Disease Registry Leaders Hybrid Roundtable Three; Deep Dive on Methods to Address the Reliability and Relevance of Registry Data for Various Uses
FDA Participant/Group: RICHARD FORSHEE;
Non FDA Participant/Group: Attendees of HHS and American Society of Hematology Sickle Cell Disease Registry Leaders Hybrid Roundtable Three

Event Date: 06/05/2023
Location: Virtual
Subject: Biotechnology Innovation Organization (BIO) International Convention; Friend and Foe: How COVID-19 Changed the Dynamic with Global Regulatory Agencies
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 06/06/2023
Location: Virtual
Subject: Wake Forest Institute for Regenerative Medicine/Regenerative Medicine Foundation 10th Annual Regenerative Medicine Essentials Course; FDA Efforts to Advance Cell and Gene Therapy Development
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Wake Forest Institute for Regenerative Medicine/Regenerative Medicine Foundation 10th Annual Regenerative Medicine Essentials Course

Event Date: 06/06/2023
Location: Virtual
Subject: Ensuring Pediatric Access to Emerging Cell and Gene Therapies Meeting; FDA Perspective
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Ensuring Pediatric Access to Emerging Cell and Gene Therapies Meeting

Event Date: 06/07/2023
Location: Virtual
Subject: Biotechnology Innovation Organization (BIO) International Convention; Realizing the Promise of Gene Therapy and Gene Editing: Current Challenges, Opportunities and Trends
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, government, and other stakeholders

Event Date: 06/07/2023
Location: Virtual
Subject: Wake Forest Institute for Regenerative Medicine/Regenerative Medicine Foundation 10th Annual Regenerative Medicine Essentials Course; Regenerative Medicine Essentials Career Panel
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Wake Forest Institute for Regenerative Medicine/Regenerative Medicine Foundation 10th Annual Regenerative Medicine Essentials Course

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 06/05/2023
Location: Virtual
Subject: Quality and Regulatory Update
FDA Participant/Group: WILLIAM MAISEL; KEISHA THOMAS; COURTNEY LIAS;
Non FDA Participant/Group: Stefan Kaufmann, Pierre Boisier, Aaron Dunbar, Todd Brill (Olympus Corporation)

Event Date: 06/07/2023
Location: Silver Spring, MD
Subject: Regulatory Science, Technology and Innovation Updates
FDA Participant/Group: ANNE REID; JOSHUA BALSAM; SUZANNE SCHWARTZ; JESSICA WILKERSON; MICHELLE TARVER; KEISHA THOMAS; ANGELA KRUEGER; LINDA RICCI; WILLIAM MAISEL; MATTHEW HAZELETT; AFTIN ROSS; BRITTANY SCHUCK; TROY TAZBAZ; MARIANELA PEREZ-TORRES;
Non FDA Participant/Group: Geoff Martha, Scott Cundy, Laura Mauri, Yarmela Pavlovic, Olaf Hedrich, Chris Reed, Chris Harrold, Jennifer Rae, Ali Dianaty, Cassie Scherer, Julio Salwen, Que Dallara (Medtronic)

Official Name: Donald Prater, Acting Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Brian King, Ph.D., Director, Center for Tobacco Products

Event Date: 06/07/2023
Location: Virtual
Subject: Maine Health - Tobacco Treatment and Prevention Conference; Speaker: Tobacco Product Regulation in the United States, An Update from FDA’s Center for Tobacco Products
FDA Participant/Group: N/A
Non FDA Participant/Group: Public health professionals, providers, and other tobacco control/community stakeholders

Official Name: Tracey H. Forfa, J.D., Director, Center for Veterinary Medicine

Event Date: 06/06/2023
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: TIMOTHY SCHELL; WILLIAM FLYNN; TRISTAN COLONIUS; SIOBHAN DELANCEY; DAVID EDWARDS; JEANETTE MURPHY;
Non FDA Participant/Group: Representatives of the American Feed Industry Association (AFIA)

Official Name: Tucker Patterson, Ph.D., Director, National Center for Toxicological Research

No Significant Event

Official Name: Mark Raza, J.D., Chief Counsel

No Significant Event

 

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