Module 1 2021

25/06/2021

A technical understanding of the tools and formats

• The more rudimentary your tool set and the more you work on the submissions yourself, the greater the need to supplement this with a technical understanding of the e- submission formats and validation rules • This is so:

• You can create the submission correctly • And troubleshoot when things go wrong

The Organisation for Professionals in Regulatory Affairs

25

Developing a Global Electronic Submission Strategy

The Organisation for Professionals in Regulatory Affairs

26

13