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  5. Public Calendar: September 10 - 16, 2017
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: September 10 - 16, 2017

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 : Scott Gottlieb, M.D., Commissioner of Food and Drugs

Event Date : 09/11/2017 - 09/11/2017
Location : Oxon Hill, MD
Subject : Regulatory Affairs Professionals Society Regulatory Convergence: FDA Actions on Addressing the Cost of Medicine and Access to Drugs
FDA Participant/Group : RAMJAY VATSAN; ROBERT TOLLEFSEN; MARC THEORET; KEISHA THOMAS; SUZANNE SCHWARTZ; KATHERINE SERRANO; DIANA YOON; SHARON WILLIAMS; FORTUNATO SENATORE; KEN SKODACEK; ALINA SALVATORE; RAJESH VENUGOPAL; YOLONDA WARREN HENDERSON; ELIZABETH VALENTI; ADAM SALTMAN; MARJORIE SHULMAN; EVELLA WASHINGTON; KELIE REECE; MICHAEL RYAN; DOROTHY WEST; CHERIE WARD-PERALTA; PAUL RICHARDS; ANDREW YEATTS; KATIE RIVERS;
Non FDA Participant/Group : Several members of Regulatory Affairs Professionals Society

Event Date : 09/12/2017 - 09/12/2017
Location : New Orleans, LA
Subject : National Association of State Departments of Agriculture Annual Meeting: New Steps to Enhance Collaboration with States and Ensure Farmers are Prepared for the Food Safety Modernization Act (FSMA)
FDA Participant/Group : JEFFREY FARRAR; CAITLIN BOON; MELINDA PLAISIER; STEPHEN OSTROFF; BARBARA CASSENS;
Non FDA Participant/Group : Several representatives from National Association of State Departments of Agriculture

Event Date : 09/13/2017 - 09/13/2017
Location : Washington, DC
Subject : Blueprint for Breakthroughs-Charting the Course for Precision Medicine: The Course of FDA in 2017
FDA Participant/Group : KATHERINE DONIGAN; JACOB RICHARDS; CHAOHONG FAN; ROBERT SCHUCK; LAURA KOONTZ; JULIE SCHNEIDER; STEVEN LEMERY; RICHARD PAZDUR; ANURADHA RAMAMOORTHY; GIDEON BLUMENTHAL; KE LIU; KELIE REECE; JEFFREY SHUREN; CHRISTIAN GRIMSTEIN; REENA PHILIP; ERNEST LITWACK; JENNIFER TOMASELLO; JENNIFER GAO; ADAM BERGER; ZIVANA TEZAK-FRAGALE; CLAIRE MYERS;
Non FDA Participant/Group : Several representatives from Friends of Cancer Research

Event Date : 09/14/2017 - 09/14/2017
Location : Washington, DC
Subject : Politico Pro Policy Summit: Regulating in the Trump Era: The Case of the FDA
FDA Participant/Group : KATHLEEN QUINN;
Non FDA Participant/Group : Representatives of POLITICO, Industry, Academia and Health Professionals

Official Name : Rachel Sherman, M.D., M.P.H.,, Principal Deputy Commissioner

No Significant Event

Official Name : Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

No Significant Event

Official Name : Dara Corrigan, Acting Deputy Commissioner for Global Regulatory Operations and Policy

Event Date : 09/12/2017 - 09/14/2017
Location : Taipei, Taiwan
Subject : Pharmaceutical Inspection Co-operation Scheme (PIC/S) 2017 Seminar
FDA Participant/Group : JADE PHAM, ELLEN MORRISON, ILISA BERNSTEIN, ALICIA MOZZACHIO
Non FDA Participant/Group : Several members from Pharmaceutical Inspection Co-Operation

Official Name : Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name : Stephen M. Ostroff, M.D., Deputy Commissioner for Foods and Veterinary Medicine

Event Date : 09/14/2017
Location : College Park, MD
Subject : Grocery Manufacturers Association: Food Safety Modernization Act Implementation
FDA Participant/Group : SUSAN KELLY; DONALD PRATER; SHARON MAYL; PATRICIA ALCOCK; WILLIAM CORRELL; JEFFREY FARRAR; JON-MIKEL WOODY; SUSAN MAYNE; KARI BARRETT; VIRGINIA SCOTT; JOHN VERBETEN; RYAN NEWKIRK;
Non FDA Participant/Group : Steve Mavity (Bumblebee); David Clifford, Greg Pritchard (Nestle); Kristen Spotz, Leon Bruner, Michael Gruber, Samantja Cooper, Shannon Cooksey, Warren Stone (Grocery Manufacturer Association); Samuel Zeller (Unilever); Joe Levitt (Hogan Lovells); Joe Meyer (Kraft Heinz); Tim Haley (Bush Brothers); Courtney Bidney (General Mills); Steve Hermansky (ConAgra Foods); Cindy Kruger (PepsiCo); Roger Lawrence (McCormick & Co.); Joseph Scimeca, Mike Robach (Cargill); Elise Binder (The Hershey Company);

Official Name : Melinda Plaisier, Associate Commissioner for Regulatory Affairs

Event Date : 09/13/2017 - 09/13/2017
Location : New Orleans, LA
Subject : National Association of State Departments of Agriculture 2017 Annual Meeting: Training Inspections and Dispute Resolution
FDA Participant/Group : N/A
Non FDA Participant/Group : N/A

Official Name : Mary Lou Valdez, M.S.M., Associate Commissioner for International Programs

No Significant Event

Official Name : Jack Kalavritinos, Associate Commissioner for External Affairs

No Significant Event

Official Name : CAPT Denise Hinton, Acting Chief Scientist

No Significant Event

Official Name : Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research

Event Date : 09/11/2017 - 09/11/2017
Location : Bethesda, MD
Subject : Surrogate Endpoint Core Group Face to Face Meeting
FDA Participant/Group : ASHLEY THOMAS; THERESA TOIGO; THERESA MULLIN; CHRISTOPHER LEPTAK; REZA KAZEMI-TABRIZ;
Non FDA Participant/Group : Cheryl Melencio; Joeseph Menetski; Gary Kelloff;Lisa McShane;Elizabeth Ottinger;Myrlene Staten (National Institute of Health); Stephen Williams (SomaLogic Incorporate); John Wagner; William Chin; Emily Morgan (Pharmaceutical Research and Manufacturers of America (PhRMA)); Stephen Williams; Kenneth Anderson; Lisa Popitz; (Harvard University); April Berry (Shawnee Mission Medical Center); James Revkin (Pfizer );

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

Event Date : 09/11/2017 - 09/11/2017
Location : Washington, DC
Subject : The Annual Parenteral Drug Association/FDA Joint Regulatory Conference
FDA Participant/Group : Several FDA Officials and Staff Members
Non FDA Participant/Group : Several members of the phamaceutical manufacturing industry

Event Date : 09/12/2017 - 09/12/2017
Location : Oxon Hill, MD
Subject : Regulatory Affairs Professionals Society Annual Convergence Meeting
FDA Participant/Group : Several FDA Officials and Staff Members
Non FDA Participant/Group : Regulatory professionals working in the medical device, pharmaceutical, and biotech industries

Event Date : 09/13/2017 - 09/13/2017
Location : Silver Spring, MD
Subject : Vaccines and Related Biological Products Advisory Committee Meeting
FDA Participant/Group : Several FDA Officials and Staff Members
Non FDA Participant/Group : Vaccines and Related Biological Products Advisory Committee members, National Institutes of Health staff, GlaxoSmithKline staff, University of Minnesota staff, members of the public and media

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

Event Date : 09/13/2017 - 09/13/2017
Location : Washington, DC
Subject : Blueprint for Breakthroughs-Charting the Course for Precision Medicine Conference
FDA Participant/Group : N/A
Non FDA Participant/Group : N/A

Event Date : 09/14/2017 - 09/14/2017
Location : Silver Spring, MD
Subject : 23andMe Personal Genome Service Reports
FDA Participant/Group : ALBERTO GUTIERREZ; ELIZABETH HILLEBRENNER;
Non FDA Participant/Group : Kathy Hibbs, Sheila Walcoff (23andMe);

Event Date : 09/15/2017 - 09/15/2017
Location : Washington, DC
Subject : Duke-Margolis mHealth Public Release Meeting
FDA Participant/Group : BAKUL PATEL; GREGORY PAPPAS;
Non FDA Participant/Group : Christina Silcox, Gregory Daniel, Mark McClellan (Duke-Margolis Center for Health Policy);

Official Name : Susan T. Mayne Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name : Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

Event Date : 09/13/2017 - 09/13/2017
Location : New York, NY
Subject : Global Tobacco and Nicotine Forum: FDA Tobacco Initiatives
FDA Participant/Group : N/A
Non FDA Participant/Group : Several members from the Global Tobacco and Nicotine Industry

Official Name : Steven Solomon, Director, Center for Veterinary Medicine

Event Date : 09/13/2017 - 09/13/2017
Location : Washington, D.C.
Subject : 2017 Parenteral Drug Association: FDA Joint Regulatory Conference
FDA Participant/Group : N/A
Non FDA Participant/Group : Parenteral Drug Association;

Official Name : William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

No Significant Event

Official Name : Rebecca K. Wood, J.D., Chief Counsel

No Significant Event

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