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  5. Public Calendar: January 24 - 30, 2021
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: January 24 - 30, 2021

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: Janet Woodcock, M.D., Acting Commissioner

Event Date: 01/26/2021
Location: Virtual
Subject: Envisioning a Transformed Clinical Trials Enterprise for 2030 - A Virtual Workshop: Part 1
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, academia, media and other registered guests

Event Date: 01/27/2021
Location: Virtual
Subject: 21st Century Precision Medicine in the Age of COVID-19
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Government, industry, academia, media and other registered guests

Event Date: 01/28/2021
Location: Virtual
Subject: Prescription Drug User Fee Act VII Ratifiers Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Vasant Narasimhan, Richard Pops, Mike Narachi, Robert Kowalski, Carl Garner, Ann Kurowski, Michelle McMurry-Heath, Steve Ubl, Richard Moscicki, James Stansel, Cartier Esham, Danielle Friend, John Murphy, Kelly Goldberg, Lucy Vereshchagina

Event Date: 01/29/2021
Location: Virtual
Subject: Proposed Clinical Trials Coordination Group Meeting
FDA Participant/Group: N/A
Non FDA Participant/Group: Andrew Badley (Mayo Clinic);

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

Event Date: 01/27/2021
Location: Virtual
Subject: Friends of the National Library of Medicine Workshop - Real World Data and Electronic Health Records in Clinical Research; Panelist: Using Real World Data in Research
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/29/2021
Location: Virtual
Subject: IQVIA Global Real World Conference; Speaker: The Changing Regulatory Landscape for Using Real World Evidence
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Official Name: Erika Anderson, Acting Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 01/26/2021
Location: Virtual
Subject: 5th Asia-Pacific Food Safety International Conference
FDA Participant/Group: N/A
Non FDA Participant/Group: Food safety professionals from government, industry and academia

Event Date: 01/27/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: JEFFREY FARRAR;
Non FDA Participant/Group: Karen Ross, Natalie Krout (California Department of Food and Agriculture);

Event Date: 01/27/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: LARRY MORRIS;
Non FDA Participant/Group: Ashley Shillingsburg (Ebay);

Event Date: 01/27/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: N/A
Non FDA Participant/Group: Dairy food executives, industry leaders, government, and academia

Event Date: 01/28/2021
Location: Virtual
Subject: Food Safety Issues of Mutual Interest
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several executives from the Consumer Brands Association, scientific and technical staff from industry

Event Date: 01/29/2021
Location: Virtual
Subject: Leafy Green Issues of Mutual Interest
FDA Participant/Group: MATTHEW LOCKEED; TRISTAN COLONIUS;
Non FDA Participant/Group: Representative Jimmy Panetta (D-CA) and staff members

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

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Event Date: 01/25/2021
Location: Virtual
Subject: Congressional Appropriations Briefing on Pfizer/Moderna Vaccine Inspections
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several Congressional appropriations majority/minority staff members

Event Date: 01/26/2021
Location: Virtual
Subject: Meeting on Risk Based Approaches to Inspections and Records Requests During and After COVID-19 Public Health Emergency
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from Association Accessible Medicines (AAM), Biotechnology Innovation Organization (BIO), Pharma and Biopharma Outsourcing Association (PBOA), Pharmaceutical Research and Manufacturers of America (PhRMA)

Event Date: 01/28/2021
Location: Virtual
Subject: Meeting on Recommendations to Support the Rapid Increase of Manufacturing Capacity for the Production of COVID-19 Therapeutics
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Representatives from Pharmaceutical Research and Manufacturers of America (PhRMA)

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

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

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

Event Date: 01/27/2021
Location: Virtual
Subject: Duke-Margolis Workshop; Speaker: Basic Research, Clinical Trial Infrastructure, and Community Engagement to Support Drug Development for Amyotrophic Lateral Sclerosis (ALS)
FDA Participant/Group: PETER MARKS;
Non FDA Participant/Group: Industry, academia, other stakeholders

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

Event Date: 01/25/2021
Location: Virtual
Subject: Institute for Gene Therapy Summit; Keynote Speaker
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/26/2021
Location: Virtual
Subject: Translate! 2021 - The Symposium on Translation in Medicine; Speaker: Accelerated Translation in Times of Global Crises
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/26/2021
Location: Virtual
Subject: Precision Medicine World Congress - 21st Century Precision Medicine in the Age of COVID-19; Speaker: Development of New SARS-CoV-2 Therapeutics
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/27/2021
Location: Virtual
Subject: CAR-T (chimeric antigen receptor T) Global Week Forum; Speaker: Clinical Trial Design and Efficacy
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/28/2021
Location: Virtual
Subject: National Foundation for Infectious Diseases Virtual Roundtable; Panelist: COVID-19 Communications: Risk, Prevention, and Vaccine Acceptance
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 01/29/2021
Location: Virtual
Subject: American Medical Association Webinar; Speaker: COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

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

Event Date: 01/25/2021
Location: Virutal
Subject: Overview of On Demand Pharmaceuticals Effort
FDA Participant/Group: FRANCISCO VICENTY; JUDITH MCMEEKIN; CAROL CAVE; DANIEL SOLIS; EDWARD MARGERRISON; ERIN KEITH;
Non FDA Participant/Group: Anne Fischer (Defense Advanced Research Projects Agency);

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

Event Date: 01/29/2021
Location: Virtual
Subject: Reassessment Petition Review
FDA Participant/Group: DENNIS KEEFE; PAUL SOUTH; LISA DAVIS; CONRAD CHOINIERE;
Non FDA Participant/Group: Several representatives from the Health and Chemical Coalition

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: 01/26/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: CHARLOTTE CONWAY; ANTONIA MONIQUE SENNETT; JEANETTE MURPHY; TRACEY FORFA; TIMOTHY SCHELL;
Non FDA Participant/Group: Representatives of the Pet Food Institute (PFI)

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

No Significant Event

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

No Significant Event

 

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