Get started early with pre-conference workshops
Data
Requirements
for an FDA
Submission
Wednesday, 26 April 2023,
from 11:15 to 16:00
We’re excited to announce a first in the SCDM EMEA Conference history – the pre-conference workshop on “Data Requirements for an FDA Submission”! It is taking place on 26 April – one day before the official programme begins.
The pre-conference workshop is an interactive 4-hour long session that provides a hands-on learning experience enabling you to gain new insights and explore new strategies and tools in your day-to-day work. It is free of charge for those attending the conference, so take this opportunity to gain more skills before the conference begins.
This session will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, PMDA).
We’re excited to announce a first in the SCDM EMEA Conference history – the pre-conference workshop on “Data Requirements for an FDA Submission”! It is taking place on 26 April – one day before the official programme begins.
The pre-conference workshop is an interactive 4-hour long session that provides a hands-on learning experience enabling you to gain new insights and explore new strategies and tools in your day-to-day work. It is free of charge for those attending the conference, so take this opportunity to gain more skills before the conference begins.
This session will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, PMDA).
Senior Director, Veeva Systems
Dan Crawford
October 10th 11.00am – 12.00am
Dan Crawford has been in the pharmaceutical industry for 25 years in both large Pharma and CROs. He has spent fifteen years in Data Management where he managed or had oversight on more than 325 clinical trials.
He specializes in authoring and presenting educational materials to the CDM industry, so you can look forward to highly structured, organized and educational workshop.
What we’ll discuss
- CDISC Overview
- Metadata Submission Model
- aCRF
- Define.XML
- Study data Reviewers Guide
- Technical Conformance Guide
- Study Data Standardization Plan
- Traceability
- Pooling of Data
- Coding
- Terminology
- EMA submission vs FDA submission
- PMDA Submissions
- FDA Review Tools
- An FDA Reviewers Approach to Clinical
Review of a Submission - Breakout sessions with exercises
