FDA Study Data Technical Conformance Guide version 4.2 – Nov. 27, 2018
FDA Study Data Technical Conformance Guide v4.2
FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019
Optimizing Your Study Data Submissions to FDA: Study Data TCG – Nov. 8, 2017
Panel Questions and Discussion (4of4) Study Data Technical Conformance Webinar – Jul. 13, 2017
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
Providing Clinical Study Data to the Office of Vaccines (2of4) Tech Conformance – Jul. 13, 2017
Study Data Submissions: Office of Vaccines Research and Review (OVRR) Data Submission – May 8, 2018
How to Prepare a Study Data Standardization Plan
What’s New for SEND 2023 Webinar
Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 4
Data Integrity from International Perspectives (2of11) GCP Data Integrity Workshop
Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality
Webinar - 2021 SEND Progress Update
CDER’s Review of the Prescribing Information (11of15) REdI– May 29-30, 2019
FDA Lecture: Advancing the Science of Patient Input in the Regulatory Settings
Requirement for Electronic Submission of an Application and Study Data - REdI 2020
PhUSE Webinar Wednesday – 27th March, 2019
Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – Sep. 27, 2018
Keynote Overview – CDER Compliance Conference
