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". 

As the title suggests, I am wondering from which day to start counting the 14 months until OMPD annual report submission. Is it 14 months from day of COMP positive opinion or from receiving EC decision/ day noted on EC letter.
 

Thank you very much for the fast reply!

Thank you very much for the answer!

I have a follow up question on the subject of translations. We have an additional clients which registered its active substance. The active substance is a DNA molecule with modifications therefore its sequence is quite complex. When registering the RPI, the substance name appears as the complex chemical sequence, however, there is a public synonym name (company code) which is short and simple. For example ABBA-23.  
in the translations, should the complex substance name (sequence)  be translated or can the short synonym be translated?

Thank you!

Liron

Dear all

For an OMPD submission, translation of the active substance/s and indication is required. 
We have a client which is using two already registered active substances as the active substances of its product. Should our client still translate these substances and the indication? only the indication? or are translations not required at all in this case?

Thank you in advance,
Liron 

Thank you! 
as a follow up question - will the follow up submission be reviewed immediately following (or close to) submission via IRIS or will it be reviewed according to the CHMP timeline for scientific advice?

Best regards,
Liron

Dear All

we would like to submit a follow up protocol to a scientific advice which took place several months ago. Is the submission deadline according to the regular scientific advice procedure deadlines published in the below link or could it be submitted at any time?

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/scientific-advice-protocol-assistance-regulatory-procedural-guidance

Thank you,
Liron

 

Thank you very Much!

On a related matter, is there a list or a demo for the filling of annual report fields in IRIS? 
This way we would know which fields need to be filled out and to what extent, and can prepare the content ahead of submission 

Best regards,
Liron

Dear all

Our client received an OMPD designation and therefore should submit an annual report in the following years. When are the annual reports due? is it similar to FDA, in which it should be submitted one year+ up to 60 days after the date of the designation? for example, if the designation was accepted on 24 April 2019, should the annual report be submitted no later than 24 June 2020.

Thank you!
Liron