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  5. Public Calendar: June 16-22, 2019
  1. FDA Meetings, Conferences and Workshops

Public Calendar: June 16-22, 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: 06/18/2019
Location: Washington, DC
Subject: Chasing Cancer: Inside FDA: The New Commissioner's Game Plan
FDA Participant/Group: SARAH PEDDICORD;
Non FDA Participant/Group: Government, academia, media, and industry

Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

Event Date: 06/18/2019
Location: Silver Spring, MD
Subject: U.S. Hemp Roundtable
FDA Participant/Group: ELIZABETH LEFF; CARA WELCH; TIMOTHY SCHELL; JOSEPH FRANKLIN; MELISSA ROBB; SHARON MAYL; MICHAEL ADAMS; APRIL ALEXANDROW; STEVEN TAVE; CHARLOTTE CONWAY; LOWELL SCHILLER; DENNIS KEEFE;
Non FDA Participant/Group: Josh Hendrix (U.S. Hemp Roundtable); Jonathan Miller (Frost Brown Todd); Ashish Talati (Amin Talati & Wasserman LLP);

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

No Significant Event

Official Name: Lowell J. Schiller, Principal Associate Commissioner for Policy

No Significant Event

Official Name: Mark Abdoo, Acting Deputy Commissioner for Global Regulatory Operations and Policy

Event Date: 06/17/2019
Location: Silver Spring, MD
Subject: Food and Drug Administration-Australian Department of Health Regulatory Update
FDA Participant/Group: SANDI VERBOIS; SEMA HASHEMI; MARY LOU VALDEZ;
Non FDA Participant/Group: John Skerritt (Australian Department of Health);

Event Date: 06/17/2019
Location: Silver Spring, MD
Subject: United States–European Union Meeting on the Mutual Recognition Agreement
FDA Participant/Group: SUSAN LASKA; THERESA MULLIN; MICHAEL OEHLSEN; JADE PHAM;
Non FDA Participant/Group: Agnes Mathieu-Mendes, Anna Ampelas, Brendan Cuddy, Dominque De Backer, Tania Teixeira (European Commission);

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

No Significant Event

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: Keagan Lenihan, Associate Commissioner for External Affairs

Event Date: 06/20/2019
Location: Silver Spring, MD
Subject: Drug Shortages
FDA Participant/Group: MARY CLARKE; RANDALL LUTTER; MICHIE HUNT; ANDREAS SCHICK;
Non FDA Participant/Group: Several representatives from Cigna

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: 06/20/2019
Location: Tysons, VA
Subject: Centre for Innovation in Regulatory Science Workshop: Knowledge Management and Quality Decision-Making
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: 06/18/2019
Location: Reston, VA
Subject: Plasma Protein Therapeutics Association: CBER Update
FDA Participant/Group: NICOLE VERDUN;
Non FDA Participant/Group: N/A

Event Date: 06/20/2019
Location: Boston, MA
Subject: International Society for Pharmaceutical Engineering: The Critical Role of Manufacturing for Advanced Therapy Medicinal Products
FDA Participant/Group: N/A
Non FDA Participant/Group: N/A

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

Event Date: 06/18/2019
Location: Silver Spring, MD
Subject: In Vitro Clinical Test Legislation
FDA Participant/Group: ELIZABETH HILLEBRENNER; TIMOTHY STENZEL; JENNIFER TOMASELLO; COURTNEY LIAS; BRITTANY SCHUCK; ELLEN FLANNERY; TOBY LOWE; KATHERINE DONIGAN;
Non FDA Participant/Group: Janet Trunzo, Susan Van Meter (Advanced Medical Technology Association); Nathan Brown (Akin Gump Strauss Hauer & Feld LLP); Michele Schoonmaker (Cepheid); Sandy Perreand (bioMérieux SA); Marilyn Waxberg (Siemens Healthineers); Brad Spring (Becton, Dickinson and Company); Danelle Miller (F. Hoffmann-La Roche Ltd);

Event Date: 06/18/2019
Location: Silver Spring, MD
Subject: 510(k) Modernization
FDA Participant/Group: WILLIAM MAISEL; ELIZABETH HILLEBRENNER; TIMOTHY STENZEL; MARJORIE SHULMAN; KATELYN BITTLEMAN; BARBARA ZIMMERMAN; ROBERT OCHS; THALIA MILLS; JOSHUA SILVERSTEIN;
Non FDA Participant/Group: Peter Weems (Medical Imaging and Technology Alliance); Jill Rathbun (Galileo Consulting Group); Diane Wurzburger (General Electric);

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

Event Date: 06/20/2019
Location: College Park, MD
Subject: Allergen Labeling
FDA Participant/Group: EMILY ROSE CAREY; DOUGLAS BALENTINE; DOUGLAS TICKER; STEFANO LUCCIOLI;
Non FDA Participant/Group: Jon Hoffman, Lisa Gable (Food Allergy Research and Education); Beth Johnson (Food Directions LLC);

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

No Significant Event

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

No Significant Event

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

No Significant Event

Official Name: Stacy Cline Amin, Chief Counsel

Event Date: 06/20/2019
Location: Silver Spring, MD
Subject: Advertising and Patient Safety
FDA Participant/Group: SARA BEARDSLEY; KAREN SCHIFTER; ELIZABETH DICKINSON;
Non FDA Participant/Group: Andrea Masciale, Jane Adams, Joseph Braunreuther, Matt Orlando, Michael Ullmann (Johnson and Johnson Services, Inc.);