EMA’s IRIS system for scientific advice opens on 19th October

As previously reported by MAP, the European Medicines Agency (EMA)’s Regulatory & Scientific Information Management Platform IRIS should be used from 19th October by developers of human or veterinary medicines to request scientific advice.
 
The developer may ask for guidance from the EMA at any stage of development on the best methods and study designs to generate robust data on the quality, efficacy and safety of a drug.
 
For human medicines, the procedures concerned are: Initial and Follow-Up Scientific Advice; Initial and Follow-up Protocol Assistance; and Initial and Follow-Up Qualification Procedure.
 
The EMA’s press release confirms that: “The IRIS platform will provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.”
 
Medicine developers must be registered to use IRIS in order to apply for scientific advice. Further information and instructions on how to register are provided in the EMA article.
 
The EMA is also offering virtual training sessions on using IRIS to request scientific advice. The session for human medicine developers will take place on 13th October. Find further information in the EMA press release.

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Published 8. October 2020 in News, News EU, Press Release