Tarita Toufexi Ms

Tarita Toufexi

Joined: 9/2/2020

  • RE: SAWP dates for 2021 ?

    Fri, 11 Jun 2021 09:06:33 GMT – SAWP dates for 2021 ?
    Following the implementation of IRIS, we are modifying our internal timelines and updating also the published documents. 
    The recent modification relates to a change in the submission of the electronic final package from ~D-3 to ~D-5 from June onwards and a change in the submission date for 30 August start of procedure from 2 August to 19 July. The specific timeline was changed to spread the validation workload  in the best possible manner, in the longer gap between SAWP meetings. 

  • RE: Request protocol assistance for one molecule under multiple ODDs

    Tue, 13 Apr 2021 15:27:25 GMT – Request protocol assistance for one molecule under multiple ODDs
    Protocol Assistance is provided for a single ODD and the system is designed accordingly to allow only one designation.
    If you have questions only on one indication you can select the relevant ODD.
    If you have questions on more than one indication, multiple requests should be created.
    However there can be exceptions depending on the content of the briefing document (broad advices not indication specific).
    For these exceptions please contact directly the Scientific Advice office for guidance at scientificadvice@ema.europa.eu.
         

  • RE: Scientific advice in IRIS- Applicant and linked organisation information

    Wed, 28 Oct 2020 11:02:24 GMT – Scientific advice in IRIS- Applicant and linked organisation information
    Response to 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)?

    Applicant should be the non-EEA SME and linked organisation the EEA SME consultant.

    Response to 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)?

    Applicant should be the holder of the orphan designation EEA SME consultant and linked organisation the non-EEA SME company.

    Response to 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?

    Same as question 1 for Scientific Advice and question 2 for Protocol Assistance. Organisations not listed in OMS should be registered.

  • RE: draft briefing document

    Wed, 28 Oct 2020 10:27:27 GMT – draft briefing document
    Dear Mr Marcinkevicius,
    thank you for your message. If you require assistance/advice on the content of the draft briefing document you can request Scientific Advice or Protoocol Assistance and select Yes in the option preparatory meeting. A teleconference will be arranged following your request to receive support by the assigned Scientific Officer.