Laurent Desqueper Mr

Laurent Desqueper

Joined: 7/14/2020

  • RPI(s) and co-formulation

    Fri, 16 Oct 2020 10:01:23 GMT – RPI(s) and co-formulation
    In case of a co-formulation with molecule 1 (which already has an RPI) and molecule 2 (no RPI yet), should we request an RPI for molecule 2 and use either RPI for any forthcoming submissions via IRIS? Or should we request an RPI for the co-formulated product (new RPI with molecules 1 and 2 referred)?

  • IRIS for Industry Companies working in Partnership

    Fri, 02 Oct 2020 14:07:18 GMT – IRIS for Industry Companies working in Partnership
    The main question is how to refer to an RPI from another company?

    We can have a combination product that combines an RPI from one company and an RPI from another company. In the paper form, it was possible to encode the RPI reference that we received from the partner. How to proceed in IRIS as we cannot see the RPIs from the other companies (which is as expected) but cannot enter the reference as received from the partner? 

  • Impact of Organization and Location selected when creating a Submission

    Fri, 02 Oct 2020 14:05:18 GMT – Impact of Organization and Location selected when creating a Submission
    We are looking at the best way to organize ourselves within our company, especially with the number of sites we have in Europe. 
    We would like to understand the impact of selecting an Organization or a Location on the outcome of the submission, either OD or SA (from business perspective). 
     
    We would also like to understand the consequences of choosing an Organization or another, a Location or another, on the visibility of RPIs, ODs, SAs… If we start a submission for a given Organization and Location, does that limit the RPIs that can be assigned to that submission? Can we link the RPIs from all Organizations linked to our profile, or only the RPIs linked to the Organization/Location selected for the ongoing submission?