The PKPD Programming Forum will meet on June 21st, 2019 from 10:30 to 12:00 EST with a focused discussion on this topic.
Submission of PK/PD/PMx files to regulatory agencies: experiences and challenges
We will review a summary of current experiences and challenges with data and analysis file submissions to regulatory agencies, specifically:
- Discuss up to date file and data submission experiences with various regulatory agencies
- Compare and contrast requests/needs of different analysis types
- Compare and contrast member experiences
- Identify gaps and emerging trends with Regulatory Agencies other than USFDA and EU.
Consider providing input to the following questions:
- Are there any other agencies that have requested population based, data, model files, or summaries, beyond what would be provided to the FDA?
- Does your experience differ w/r the types of files requested or submitted?
- What have been the most challenging aspects of data and model file submission for your company?
- How consistent has your submission experience been across departments within the same agency? E.g., CBER, CDER, vs others.
- What has been your experience and consistency with agencies that outsource pharmacometric review, e.g., Australia?
- Are there specific agencies you prefer to work with over others (successes vs. challenges)?
- Have any challenges with data integrity converting back and forth between SAS transport files (e.g., data format, issues with forcing data from ASCII text to SAS Transport and back)?
- Are there specific best practices that work for your company to ensure successful submissions (e.g., content clarification meetings)?
- We have heard that the FDA will now accept files in their native format and nomenclature (original file name, not in SAS transport format), as long as they are ASCII text format, Had your company started taking advantage of this? Have you even heard that this is possible?
All are welcome to join in the conversation.
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Conference ID: 674294