Module 12 2019

Standards Best Practice

• Institutionalize a global approach in a “Guidance Interpretation” document that captures document, data, and submission standards • Provide an interpretation of existing guidance and regulations from which internal standards, working practices, etc. are created • Clarify how to address/resolve those areas not clearly defined within the guidance and regulations

• Define the process for deviation

Benefits

● Reduces confusion where guidance is unclear

● Improves delivery of e-submission ready documents

● Establishes global consistency

● Reduces re-work potential

● Increases efficiency

The Organisation for Professionals in Regulatory Affairs