I'm looking to get people's experience with submitting Investigational Medicinal Product Dossiers (IMPDs). Specifically, their experience on whether you submit a Complete IMPD (which includes nonclinical, clinical, and risk-benefit data) vs a Simplified IMPD, which is essentially just Quality/CMC information with cross-references to the Investigator's Brochure and clinical protocol for the nonclinical, clinical, and risk-benefit data. My limited experience has been using a Simplified IMPD which was driven by recommendation from our CRO (Medpace). This was mainly based on 1) Simplified is acceptable per EU guidance (see attached) and 2) ease of life-cycle management. This approach was successful with a couple of previous CTAs as we did not receive any requests from any EU countries to convert to a Complete IMPD. Most of my colleagues are on board with continuing with the Simplified approach for our next study, but we have a new Chief Medical Officer that joined recently and their experience has always been to use a Complete IMPD. Are there certain instances where it is better to use a Complete IMPD? Or is it up to the sponsor? Obviously we want to avoid delaying study start in the event we submit a Simplified only to have a Competent Authority come back and request Complete. Note, we will likely have study sites in new countries we didn't use in the previous studies I mention. Would appreciate hearing about other's experiences and thoughts.
Thank you.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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