Posted Thu, 02 May 2024 07:47:28 GMT by Liron Gibbs-Bar Senior Regulatory and Scientific Consultant
We are interested in having a Preparatory scientific advice meeting and are wondering what is required to be submitted for this meeting. I found a Q and A guideline  however it's for veterinary scientific advice- Guidance for applicants requesting scientific advice  5 October 2020 EMA/CVMP/11887/2020  
Would this excerpt, taken from the veterinary guideline also apply for a regular scientific advice? if not- what would the required content be?
"Applicants can request preparatory meeting using the electronic submission form in IRIS (Procedural information section) and specify their preferred week for the meeting. In such a case please upload the proposed list of issues/topics to be discussed and the list of proposed attendees (mandatory), and any relevant background information (optional; e.g. draft product profile, overview of the development plan, presentation slides, etc.) in the Documents from Applicant section of the electronic submission form in IRIS". 
Posted Tue, 07 May 2024 13:16:48 GMT by Paolo Tomasi EMA
The request for a preparatory meeting is done within the application for Scientific Advice, in the "procedural information" section. See attached screenshot. 

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