Electronic Submissions Presentations
SBIA Regulatory Education for Industry (REdI) Annual Conference, Virtual
June 6, 2022
- FDA Study Data Technical Rejection Criteria (TRC): What you need to know! – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- eCTD Updates – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- CDER NextGen Portal – Seyoum Senay, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- Electronic Submissions Gateway (ESG) Transparency and Modernization – J. Lowell Marshall, Office of Information Management and Technology, Office of Digital Transformation, OC
- Standardizing Quality Submissions and Assessments: PQ/CMC and KASA – Norman Schmuff, Associate Director, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, CDER
Pharma SUG 2022, Virtual, Jiang Xu, Lina Cong
May 22-25, 2022
PHUSE US Connect 2022, Atlanta, Jiang Xu, Lina Cong
May 1 – 4, 2022
FDA/CDER CDISC-SEND Spring Face-to-Face, Virtual
April 27, 2022
- Study Data Technical Rejection Criteria – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PDUFA VI Public Meeting, Virtual
April 12, 2022
- FDA Study Data Technical Rejection Update – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- FDA eCTD Update – Mark Gray, Senior Project Manager, Data Standards Branch, CBER
DIA Regulatory Submissions, Information, and Document Management Forum, North Bethesda, MD “Virtual”
February 14-16, 2022
- Technical Rejection Criteria for Study Data – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- FDA Forms Update – Daniil Graborov, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- Electronic Submissions Update – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- CDER NextGen Portal – Seyoum Senay, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PharmaSUG, Single Day Event, China “Virtual”
November 12, 2021
- FDA Study Data Technical Rejection Update – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
GRx+Biosims, Virtual
November 8-10, 2021
- eCTD Validations and Study Data – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
R/Pharma, Virtual
November 2-4, 2021
- Submitting Data to CDER: Requirements for your Application – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
FDA/CDER CDISC-SEND Fall Face-to-Face, Virtual
November 3, 2021
- Study Data Technical Rejection Criteria – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
Pharmaceutical Regulatory Operations & Submissions Conference, Virtual
October 4-5, 2021
- eCTD Guidance and Specifications Updates – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PhUSE Computational Science Symposium (CSS), Virtual
September 13-15, 2021
- A regulatory journey from PDUFA, FDASIA, and Guidances for standardized study data – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
SBIA Regulatory Education for Industry (REdI)
Annual Conference
July 19-23, 2021
- Electronic Common Technical Document (eCTD) – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PhUSE US Connect 2021
June 14-18, 2021
- How to submit datasets in study data submissions to comply with Technical Rejection Criteria - Lina Cong, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- Data-driven CDER Regulatory Review: Now and Future - Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- FDA Conformance Analysis and Upcoming Implementation of Technical Rejection Criteria for Study Data - Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER and Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PharmaSUG 2021
May 26, 2021
- FDA Study Data Technical Rejection Update - Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
SBIA Webinar
May 21, 2021
- FDA Study Data Technical Rejection Criteria (TRC): What you need to know! – Jiang Xu and Lina Cong, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
PDUFA VI Public Meeting
April 7, 2021
- FDA Study Data Technical Rejection Update - Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
DMF Workshop
March 3-4, 2021
- Managing Electronic DMF Submissions - Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
DIA RSIDM 2021
Feb 8-10, 2021
- Technical Rejection Criteria for Study Data - Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
- FDA Electronic Submissions Update – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
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
- 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 Even
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
Please contact esub@fda.hhs.gov, if you have any questions about the presentations included on this page.