Module 3 2019

How QPs assure CTA compliance

Internal Processes that ensure the PSF matches the CTA

The sponsor may take responsibility for this after certification

Robust Change Control - Including Regulatory Change Control - Including Approval Commitments Visibility of current regulatory commitment - Do and Tell ---> Tell and wait approval

Visibility of initial approval status for the CTA

Visibility of amendment approval status for amendments to the CTA

The Organisation for Professionals in Regulatory Affairs