CRED ERP 25

5. Interacting with the EMA/(co-)Rapporteurs

(Co-)Rapporteur Pre-Submission Meeting(s) These meetings are important because they serve to build a dialogue between the Rapporteurs and the applicant. This is important because the Rapporteurs will act as primary reviewer and product champion when discussing issues with the CHMP. The better briefed the Rapporteurs are on the key issues and the company position on them, the better they can explain and discuss these issues when they are under review by the CHMP. For differences in content and structure for advanced therapy filings, EMA recommends early pre-submission meetings and requesting appointment of rapporteurs as early as possible to facilitate dialogue during the MAA preparation. Key points: • Determine whether joint or separate (Co-)Rapporteur meeting(s) is appropriate taking (Co-)Rapporteur preferences into consideration • Face-to-face meetings are normally preferable depending on availability • Invite/keep the EMA Project Manager informed • Provide the briefing package to the (Co-)Rapporteur as far in advance as possible of the meeting • Agree timelines with (Co-)Rapporteur, generally 2-4 weeks in advance o Contact (Co-)Rapporteur in advance to determine preferred meeting structure o Presentation and discussion versus discussion only o Level of background discussion required prior to issues discussion • Provide a summary of relevant quality, non-clinical & clinical data • Summarise main issues with supporting data package, associated list of questions and accompanying company position • Be transparent and honest about the issues • Be strategic about questions posed; do not ask questions for which company is not prepared for the answer; focus on what needs to be addressed • General rule – do not ask for “open” advice if the company is not prepared to follow it • Ensure appropriate functional area representation in order to be able to address issues raised (the number of attendees is limited; do not bring more company representatives than there are authority attendees) • Determine (Co-)Rapporteur level of concern and/or position on individual issues by review ofinformation in the public domain o EPARs o Guidance they might have provided input on o Colleagues ’ experience of the agencies • Provide draft minutes of meeting to (Co-)Rapporteur and EMA • Include minutes of meeting in MAA.