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  1. Electronic Regulatory Submission and Review

Electronic Submissions Presentations

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 Event
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

 

Association for Accessible Medicines
GRx + Biosims 2018
September 6, 2018, Baltimore, MD

DIA Global Boston 2018
June 24-28, 2018, Boston, MA

PhUSE US Connect
June 3-6, 2018, Raleigh, NC

FDA/CDER Small Business and Industry Assistance (CDER SBIA) Generic Drug Forum (GDF) 2018
April 12, 2018  

DIA Regulatory Submissions, Information, and Document Management Forum
February 5-7, 2018, North Bethesda, MD

  • Electronic Submissions Update, Ethan Chen, Acting Director, Division of Data Management Services and Solutions, Office of Business Informatics, CDER

AAM FallTech
November 6-8, 2017, North Bethesda, MD

DIA North Bethesda Feb 2017
February 6-8, 2017, North Bethesda, MD

General Updates, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

RAPS Regulatory Convergence
September 17-20, 2016, San Jose, CA

DIA Annual Meeting
June 26-30, 2016, Philadelphia, PA

DIA Regulatory Submissions, Information, and Document Management Forum
February 8-10, 2016, North Bethesda, MD

FDA/CDER Small Business and Industry Assistance (CDER SBIA) New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know
February 4, 2016

GPhA Fall Technical Conference
November 4, 2015, North Bethesda, MD

DIA eRegulatory and Intelligence Annual Conference
May 11-13, 2015, Philadelphia, PA

FDA/CDER Small Business and Industry Assistance (CDER SBIA) GDUFA and You Conference 2014 March 27, 2014

  • eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Quality and Product Data Standards, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Study Data Standards Update, Ron Fitzmartin, PhD, MBA, Office of Strategic Programs, CDER
  • Top Ten Issues with Data, Douglas Warfield, Ph.D., Division of Data Management Services & Solutions, Office of Business Informatics, CDER

2013 GPhA/FDA ANDA Labeling Workshop / USP Forum September 11, 2013

Please contact esub@fda.hhs.gov, if you have any questions about the presentations included on this page.

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