Rainer Paffenholz Dr

Rainer Paffenholz

Joined: 8/20/2018

  • Change in Sponsors Primary Contact

    Tue, 14 Sep 2021 17:51:41 GMT – Change in Sponsors Primary Contact
    Hello 
    if, for an existing regulatory entitlement (an existing ODD in this case), the name "Sponsors Primary Contact" has left the company, how can a new "Sponsors Primary Contact" be added?
    Thank you! 

  • Scientific advice in IRIS- Applicant and linked organisation information

    Wed, 21 Oct 2020 11:23:54 GMT – Scientific advice in IRIS- Applicant and linked organisation information
    Can you please clarify the following:

    Question 1:

    Company A is a non EEA SME holding SME status via an EEA consultancy which itself is also SME. Company A would like to request Scientific Advice for a non-orphan product. Which entity is the applicant for the SA (Company A or Consultancy B)?

    Question 2:

    Company A is a non EEA SME holding SME status via an EEA consultancy (Consultancy B) which is itself also SME. Company A would like to request Protocol Assistance for their orphan product. The sponsor of this ODD is the Consultancy B. Which entity is the applicant for the SA (Company A or Consultancy B)?

    Question 3:

    Company A is a non EEA SME holding SME status via an EEA consultancy which itself is also SME. Both have several linked and partner enterprises as described in their SME applications. Some of these are not active in the pharmaceutical industry and are not registered in OMS.

    What information is required in section “Linked organization information”. How to handle linked organisations not listed in OMS?