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  1. Electronic Regulatory Submission and Review

Electronic Submissions Presentations

SBIA Regulatory Education for Industry (REdI)
Annual Conference

July 19-23, 2021

PhUSE US Connect 2021

June 14-18, 2021

PharmaSUG 2021

May 26, 2021

SBIA Webinar

May 21, 2021

PDUFA VI Public Meeting

April 7, 2021

DMF Workshop

March 3-4, 2021

DIA RSIDM 2021

Feb 8-10, 2021

PharmaSUG, Single Day Even

October 23, 2020

  • Electronic Submissions Update - from eCTD to CDISC Implementation and Beyond, Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

DIA Regulatory Submissions, Information, and Document Management

February 10-12, 2020, North Bethesda, MD

  •  FDA Digital IND Safety Reporting, Ginny Hussong, Data Standards, CBER (Chair)
    • FDA’s Implementation of Digital IND Safety, Meredith K. Chuck, M.D., Acting Associate Director for Safety, OOD/OND/CDER
    • FAERS II Status Update for IND Safety, Suranjan De, M.D., MBA, Deputy Director, RSS/OND/CDER
    • Safety Reporting Portal Update, Vali M. Tschirgi, Project Manager, Office of the Director, CBER
  • FDA Plenary Session, Ron Fitzmartin, Office of the Director, CBER (chair)
    • CDER-CBER Data Standards Program Overview, Ray Wang, Office of Strategic Programs, CDER
    • The Implementation of Structured Product Labeling (SPL) in HL7 FHIR, Scott Gordon, Office of Strategic Programs, CDER
    • Technical Rejection Criteria for Study Data, Ethan Chen, Office of Business Informatics, CDER
       
  • Technical Rejection Criteria for Study Data and Self-Check Worksheet, Heather Crandall, Division Data Management Services and Solutions, Office of Business Informatics, CDER

FDA/CDER CDISC-SEND Fall Face to Face

November 6, 2019, Silver Spring, MD

Association for Accessible Medicines
GRx + Biosims 2019

November 4, 2019, North Bethesda, MD

PhUSE Single Day Even

September 26, 2019, Silver Spring, MD

 VI International Symposium on Biopharmaceutical Statistics

August, 2019, Kyoto, Japan

DIA Annual Global 2019

June 25-28, 2019, Boston, MA

  • FDA Electronic Submissions Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Update on Technical Rejection Criteria for Study Data, Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Study Data Technical Rejection Criteria, Validation, and Self-Check Worksheet, Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

PhUSE Annual Computational Science Symposium

June 10, 2019, Silver Spring, MD

FDA/CDER Small Business and Industry Assistance (CDER SBIA) Generic Drug Forum (GDF) 2019

April 3-4, 2019, College Park, MD

FDA/CDER CDISC-SEND Spring Face to Face

April 3, 2019, Silver Spring, MD

PhUSE US Connect 2019

February 27, 2019, College Park, MD

DIA Regulatory Submissions, Information, and Document Management Forum

February 11-13, 2019, North Bethesda, MD

Please contact [email protected], if you have any questions about the presentations included on this page.

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