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  5. Public Calendar: November 7-13, 2021
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: November 7-13, 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: 11/08/2021
Location: Virtual
Subject: GRx+Biosims Generics and Biosimilars Conference; Speaker
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, and media

Event Date: 11/08/2021
Location: Virtual
Subject: National Academy of Medicine; Committee on Emerging, Science, Technology and Innovation Meeting
FDA Participant/Group: JANET OSHAUGHNESSY;
Non FDA Participant/Group: Victor Dzau (National Academy of Medicine);

Event Date: 11/09/2021
Location: Virtual
Subject: Friends of Cancer Research Annual Meeting - Getting Better Cancer Treatments to Patients; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, and media

Event Date: 11/10/2021
Location: Virtual
Subject: Trial Updates and Protocols
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

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

Event Date: 11/09/2021
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Digital Health Technology and Regulation Conference; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Government, industry, non-profit, and other registered participants

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

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

Event Date: 11/12/2021
Location: Virtual
Subject: Chartered Institute of Environmental Health's Safe Food Conference - New Era of Smarter Food Safety; Speaker: Keynote Address
FDA Participant/Group: N/A
Non FDA Participant/Group: Environmental health and food safety professionals from industry, academia, and government

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

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: Jacqueline O'Shaughnessy, Acting Chief Scientist

No Significant Event

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

Event Date: 11/08/2021
Location: Virtual
Subject: 13th Annual Sentinel Initiative Public Workshop; Speaker: Keynote Address
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 11/08/2021
Location: Virtual
Subject: Model-Informed Drug Development (MIDD) Pilot Program Workshop; Speaker: Opening Remarks
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 11/10/2021
Location: Virtual
Subject: International Society of Pharmacovilgence (ISoP) Annual Meeting; Speaker: Integrated Pharmacovigilance for Safer Patients
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, and other stakeholders

Event Date: 11/10/2021
Location: Virtual
Subject: International Coalition of Medicines Regulatory Authorities (ICMRA) Executive Committee Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Members of the Executive Committee

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

Event Date: 11/07/2021
Location: Virtual
Subject: American College of Allergy, Asthma & Immunology 2021 Annual Scientific Meeting; Development of Biologics for COVID-19 Disease; Innovating Our Way Out of the Pandemic: Vaccines and Therapeutics
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of American College of Allergy, Asthma & Immunology 2021 Annual Scientific Meeting

Event Date: 11/08/2021
Location: Virtual
Subject: Defense Intelligence Agency's Advanced Therapies: Innovations in CMC Conference; The Transformational Potential of the Advanced Manufacturing of Biologics
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of Defense Intelligence Agency's Advanced Therapies: Innovations in CMC Conference

Event Date: 11/08/2021
Location: Virtual
Subject: American Society of Gene & Cell Therapy/FDA Liaison Meeting
FDA Participant/Group: RACHAEL ANATOL; WILSON BRYAN; CELIA SILVERMAN;
Non FDA Participant/Group: Attendees of American Society of Gene & Cell Therapy/FDA Liaison Meeting

Event Date: 11/12/2021
Location: Virtual
Subject: National Indian Health Board #ActofLove Webinar: COVID-19 Vaccines: What Do I Need to Know; Facilitating the Development of COVID-19 Vaccines
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of National Indian Health Board #ActofLove Webinar

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

Event Date: 11/12/2021
Location: Virtual
Subject: SAFE (Stop the Addiction Fatality Epidemic) Project Meeting
FDA Participant/Group: KELLIE KELM; JOSEPH KOTAREK;
Non FDA Participant/Group: Mary Bono (Mothers Against Prescription Drug Abuse (MAPDA)); Brandee Izquierdo, Jeff Horwitz (SAFE Project); Barrye Price (Community Anti-Drug Coalitions of America);

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

No Significant Event

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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