AAM GRx+Biosims, North Bethesda, MD

October 28, 2025

FDA Electronic Submissions (EXPO BOOTH) – Jonathan Resnick, Heather Crandall, Seyoum Senay, Megan Boals, Sajid Khan, Office of Business Informatics, CDER

AAM GRx+Biosims, North Bethesda, MD

October 21, 2024

eCTD v4 Implementation Updates – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
Update on eCTD Submissions – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
What’s New with Electronic Submissions? (EXPO BOOTH) – Jonathan Resnick, Heather Crandall, Seyoum Senay, Megan Boals, Sajid Khan, Office of Business Informatics, CDER

October 3, 2023

SBIA Regulatory Education for Industry (REdI) Annual Conference, Virtual

June 5, 2023

eCTD Updates – Heather Crandall, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
eCTD v4.0 Implementation Update – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

SEND Face-to-Face, Virtual

April 24, 2024

April 23, 2023

SBIA Generic Drug Forum, Virtual

April 13, 2023

PHUSE US CONNECT 2023, Bethesda, MD

March 8, 2023

DIA Regulatory Submissions, Information, and Document Management Forum, North Bethesda, MD

February 12-14, 2024

eCTD v4.0 Implementation Update – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
Update on eCTD Submissions – Heather Crandall, 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

February 13 – 15, 2023

eCTD v4.0 Implementation Update – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
Study Data Technical Rejection Criteria Update – Lina Cong, 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
Standardizing Quality Submissions and Assessments: PQ/CMC and KASA – Norman Schmuff, Associate Director, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, CDER
Application Submission and Filing Review Process – Ethan Chen, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

PharmaSUG SDE, Research Triangle, NC

October 21, 2022

PHUSE CSS 2022, Silver Spring, MD

September 25, 2022

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

PDUFA VI Public Meeting, Virtual

April 12, 2022

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

GRx+Biosims, Virtual

November 8-10, 2021

R/Pharma, Virtual

November 2-4, 2021

FDA/CDER CDISC-SEND Fall Face-to-Face, Virtual

November 3, 2021

Pharmaceutical Regulatory Operations & Submissions Conference, Virtual

October 4-5, 2021

PhUSE Computational Science Symposium (CSS), Virtual

September 13-15, 2021

SBIA Regulatory Education for Industry (REdI)
Annual Conference

July 19-23, 2021

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

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

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

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

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.