Electronic Submissions Presentations

FDA/CDER CDISC-SEND Fall Face to Face
November 6, 2019, Silver Spring, MD

• Study Data Technical Rejection Criteria, Validation, and Self-Check Worksheet, Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

Association for Accessible Medicines
GRx + Biosims 2019
November 4, 2019, North Bethesda, MD

• Electronic Submissions: eCTD Update, Jonathan Resnick, Division Data Management Services and Solutions, Office of Business Informatics, CDER

• Study Data Technical Rejection Criteria, Validation, and Self-Check Worksheet, Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

PhUSE Single Day Event
September 26, 2019, Silver Spring, MD

• Study Data Technical Rejection Criteria, Validation, and Self-Check Worksheet , Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

 VI International Symposium on Biopharmaceutical Statistics
August, 2019, Kyoto, Japan

• Study Data Technical Rejection Criteria, Validation, and Self-Check Worksheet, Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

• Update on Technical Rejection Criteria for Study Data, Ethan Chen, Division Data Management Services and Solutions, Office of Business Informatics, CDER

FDA/CDER Small Business and Industry Assistance (CDER SBIA) Generic Drug Forum (GDF) 2019
April 3-4, 2019, College Park, MD

• Update on Technical Rejection Criteria for Study Data, Ethan Chen, Division Data Management Services and Solutions, Office of Business Informatics, CDER
• Practical Tips on eCTD, Jonathan Resnick, Division of Data Management Services and Solutions, Office of Business Informatics, CDER

FDA/CDER CDISC-SEND Spring Face to Face
April 3, 2019, Silver Spring, MD

• Update on Technical Rejection Criteria for Study Data , Heather Crandall, Division Data Management Services and Solutions, Office of Business Informatics, CDER

PhUSE US Connect 2019
February 27, 2019, College Park, MD

• FDA View: Update on Technical Rejection Criteria for Study Data, Ethan Chen, Division Data Management Services and Solutions, Office of Business Informatics, CDER; Virginia Hussong, Data Standards Program, CBER

DIA Regulatory Submissions, Information, and Document Management Forum
February 11-13, 2019, North Bethesda, MD

• Electronic Submissions, eCTD Submission Metrics and Guidance, Jonathan Resnick, Division of Data Management Services and Solutions, Office of Business Informatics, CDER
• Technical Rejection Criteria for Study Data, Ethan Chen, Division Data Management Services and Solutions, Office of Business Informatics, CDER; Virginia Hussong, Data Standards Program, CBER

 

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

• Electronic Submissions: eCTD Metrics and Challenges, Jonathan Resnick, Division Data Management Services and Solutions, Office of Business Informatics, CDER

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

• FDA Electronic Submissions Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

• FDA View: Technical Rejection Criteria for Study Data, Ethan Chen, Office of Business Informatics, CDER, Lilliam Rosario, Office of Computational Science, CDER, Ron Fitzmartin, Data Standards Team, CDER, and Virginia Hussong, CBER

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

• Challenges & Expectations for BE Site and Manufacturing Facility Information in Applications, Jia Jian Shen, Division Data Management Services and Solutions, Office of Business Informatics, CDER and Derek S. Smith, Ph.D., Branch Chief, Office of Process and Facilities, CDER
• eCTD Submissions, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

• Office of Business Informatics, Office of Strategic Programs Booth

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

• Electronic Submissions Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

• Electronic Submissions Update, Ginny Hussong, Director, Division of Data Management Services and Solutions, Office of Business Informatics, CDER
• Electronic Submissions Gateway (ESG), La Misha Fields, Program Manager, OIMT
• Electronic Submissions Gateway: Next Generation eCTD v4.0 Two-Way Communication, Mark Gray, Senior Project Manager, CBER

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

• Electronic Submissions Update, Ginny Hussong, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER (PDF - 483 KB)
• eCTD Validation Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER (PDF - 435 KB)
• Global Identification of Medicinal Products (IDMP), Vada Perkins, CAPT, USPHS, Office of the Center Director, CBER (PDF - 2.3 MB)

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

• New Requirement for Electronic Submission of DMFs, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

• New Requirement for Electronic Submission of DMFs, Ginny Hussong, Director (Acting), Division of Data Management Services & Solutions, Office of Business Informatics, CDER (PDF - 1 MB)

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

• Electronic Submissions Update, Ginny Hussong, Director (Acting), Division of Data Management Services & Solutions, Office of Business Informatics, CDER
• FDA Update: Submission of Promotional Materials, CDR Roberta Szydlo, RPh, MBA, RAC, Senior Regulatory Review Officer, Office of Prescription Drug Promotion, CDER
• FDA’s Module 1 Update, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
• eCTD IV Update, Mark Gray, Senior Project Manager, CBER

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

• Optimizing your eCTD ANDA, Jared Lantzy, PMP, Data Management Solutions Team, Office of Business Informatics, CDER 

• EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context: FDA Update/Progress Report December 5, 2013 (PDF)

• 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

• Submitting High Quality eCTD Submissions to FDA/OGD, Constance Robinson, Regulatory Information Specialist, Electronic Submission Support Team, Office of Business Informatics, CDER (PDF - 414KB)  

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

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