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Pre-Conference Workshop

The very 1st one in the history of EMEA Conference!

Data
Requirements
for an FDA
Submission

Wednesday, 26 April 2023,
from 11:15 to 16:00
We’re excited to have organized a first in the SCDM EMEA Conference history – the pre-conference workshop on “Data Requirements for an FDA Submission”! It took place on 26 April – one day before the official programme began and it was a great success!

 

The pre-conference workshop was an interactive 4-hour long session that provided a hands-on learning experience enabling you to gain new insights and explore new strategies and tools in your day-to-day work.

 

This session provided an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, PMDA).
We’re excited to have organized a first in the SCDM EMEA Conference history – the pre-conference workshop on “Data Requirements for an FDA Submission”! It took place on 26 April – one day before the official programme began and it was a great success!

 

The pre-conference workshop was an interactive 4-hour long session that provided a hands-on learning experience enabling you to gain new insights and explore new strategies and tools in your day-to-day work.

 

This session provided an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, PMDA).
Dan Crawford - workshop

Dan Crawford

Senior Director, Veeva Systems

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 discussed

  • 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