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  5. Public Calendar: September 15-21, 2019
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: September 15-21, 2019

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: Norman E. Sharpless, M.D. (Acting), Commissioner of Food and Drugs

Event Date: 09/18/2019
Location: Washington, DC
Subject: 8th Annual Blueprint for Breakthrough Forum: Validating Real-World Endpoints for an Evolving Regulatory Landscape
FDA Participant/Group: JANET WOODCOCK; PALLAVI MISHRA-KALYANI; AMY ABERNETHY; SEAN KHOZIN; STEPHANIE CACCOMO; JACQUELINE CORRIGAN CURAY;
Non FDA Participant/Group: Academia, government, industry and media

Event Date: 09/20/2019
Location: Silver Spring, MD
Subject: 24th Annual FDA United States Public Health Service Commissioned Corps Promotion Ceremony
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: N/A

Official Name: Amy Abernethy, M.d.,Ph.D, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

Event Date: 09/19/2019
Location: Baltimore, MD
Subject: American Heart Association Research Leaders Academy
FDA Participant/Group: N/A
Non FDA Participant/Group: American Heart Association awardees, leadership, and other attendees from academia and industry

No Significant Event

Official Name: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Dara Corrigan, Deputy Commissioner for Policy, Planning, Legislation, and Analysis

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

Event Date: 09/17/2019
Location: Silver Spring, MD
Subject: Food Safety Issues
FDA Participant/Group: N/A
Non FDA Participant/Group: Angela Fernandez, Bob Carpenter (GS1 US);

Event Date: 09/18/2019
Location: Washington DC
Subject: United Fresh Washington Public Conference
FDA Participant/Group: N/A
Non FDA Participant/Group: Food industry executives, associations, and government

Event Date: 09/18/2019
Location: College Park, MD
Subject: Produce Safety Issues of Mutual Interest
FDA Participant/Group: DONALD PRATER; JAMES GORNY; LAUREN BERKOWITZ; DOUGLAS STEARN; WILLIAM CORRELL; AMY BARRINGER; JEFFREY FARRAR; CATHERINE MCDERMOTT; LARRY MORRIS; MICHAEL ROGERS;
Non FDA Participant/Group: Jennifer McEntire (United Fresh Produce Association); Lance Peterson (Super Starr International ); Juan Carlos Martinez (Sunrise Produce); Edgar Millan (Caraveo Papayas); Dante Galeazzi (Texas International Produce Association);

Event Date: 09/20/2019
Location: Silver Spring, MD
Subject: Quarterly Safe Food Coalition Meeting
FDA Participant/Group: Office of Food Policy and Response, Center for Food Safety and Applied Nutrition, and Office of Regulatory Affairs
Non FDA Participant/Group: Consumer, public health, and academic organizations

Official Name: Lowell Schiller, Principal Associate Commissioner for Policy

Event Date: 09/18/2019
Location: FDA, White Oak Campus, Bldg 32, Conference Room 4344
Subject: Medical Information Working Group (MIWG) Meeting
FDA Participant/Group: LAUREN ROTH; DIANE MALONEY; ELLEN FLANNERY; ANAN LOLOEI; COLIN ROM; KAREN SCHIFLER; KATIE GRAY; KELLEY NDOUM; GRAIL SIPES; PHIL CHAO
Non FDA Participant/Group: Joshua Oyster (Ropes & Gray, LLP); Kelly Combs (Ropes & Gray, LLP); Matthew Garrison (Novartis Pharmaceuticals); Coleen Klasmeier (Sidley Austin, LLP)

Official Name: Melinda Plaisier, Associate Commissioner for Regulatory Affairs

No Significant Event

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

No Significant Event

Official Name: John Kalavritinos, Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

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

Event Date: 09/17/2019
Location: Rockville, Maryland
Subject: Rare Disease Cures Accelerator Data and Analytics Platform Launch Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

Event Date: 09/17/2019
Location: Washington DC
Subject: The 2019 Roundtable Discussion: FDA Trends in Real-World Evidence, Digital Technology, and Medical Device Approvals, and Potential Impacts on Medical Care for Older Adults
FDA Participant/Group: JEFFREY SHUREN;
Non FDA Participant/Group: N/A

Event Date: 09/18/2019
Location: Washington, DC
Subject: 8th Annual Blueprint for Breakthrough Forum: Establishing a Framework to Operationalize and Validate Real-World Data Sets
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 09/15/2019
Location: Miami Beach, FL
Subject: Cord Blood Connect: Advancing the Development of Stem Cell Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the cord blood community

Event Date: 09/16/2019
Location: Bethesda, MD
Subject: Public Workshop: Developing Therapeutics for Alpha-1 Antitrypsin Deficiency
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from NIH and Alpha-1 Foundation

Event Date: 09/17/2019
Location: Silver Spring, MD
Subject: International Society of Stem Cell Research: Liaison Meeting
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several representatives from the International Society of Stem Cell Research

Event Date: 09/18/2019
Location: Washington, DC
Subject: Parenteral Drug Association/FDA Joint Regulatory Conference: Facilitating the Development of Advanced Therapies
FDA Participant/Group: Several FDA officials and staff members
Non FDA Participant/Group: Several attendees from the Parenteral Drug Association

Event Date: 09/19/2019
Location: Washington, DC
Subject: Congressional Briefing on Regenerative Cell Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: Several Congressional staff members; several representatives from the Alliance for Cell Therapy Now

Event Date: 09/20/2019
Location: Newark, NJ
Subject: BioNJ Manufacturing Briefing: Advancing the Development of Gene Therapy
FDA Participant/Group: N/A
Non FDA Participant/Group: Several representatives from the BioNJ industry

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

Event Date: 09/17/2019
Location: Silver Spring, MD
Subject: Pharmacogenetic Testing
FDA Participant/Group: KATHERINE DONIGAN; TIMOTHY STENZEL; ELLEN FLANNERY; ELIZABETH HILLEBRENNER; BRITTANY SCHUCK; COURTNEY LIAS;
Non FDA Participant/Group: Cynthia Bens, Daryl Pritchard, David Davenport (Personalized Medicine Coalition);

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

No Significant Event

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

Event Date: 09/19/2019
Location: Rockville, MD
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: TIMOTHY SCHELL; KRISTINA GODDARD; ASHLEY STEEL; HEATHER LOMBARDI; MICHAEL MURPHY; JEANETTE MURPHY; WILLIAM FLYNN; SIOBHAN DELANCEY; MATTHEW LUCIA; TRACEY FORFA; JULI ANN PUTNAM; ANTONIA MONIQUE SENNETT; ANNE NORRIS;
Non FDA Participant/Group: Several members from the National Pork Producers Council

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

No Significant Event

Official Name: Stacy Cline Amin, Chief Counsel

No Significant Event