CRED 8 Presentations

01/07/2024

Interacting with the EMA and Committees

The Organisation for Professionals in Regulatory Affairs

27

Interacting with the EMA/(co-)Rapporteur/PRAC

Further info to come in theory vs reality

• Points of interaction • F2F pre-submission meetings with (Co-)Rapporteurs: Introduce product development, dossier content, clarify issues and address any preliminary questions • Clarification meetings during procedure (e.g. D120, D180): to confirm mutual understanding of questions and evaluate if proposed response strategy is acceptable • Oral explanation (and prior to oral explanation if possible) • EMA Product Lead is the main point of contact through procedure • Will triage questions/requests/information to (co-)Rapporteurs as needed (do not contact them directly!) • Keep in close contact with the Product Lead; be as transparent as possible • Remember your Product Lead and (Co-)Rapporteurs are people • Critical to build good relationships based on trust and mutual understanding

Abbreviations: F2F = face-to-face, LoQ = List of questions; LoOI = List of outstanding issues, TC = teleconference

The Organisation for Professionals in Regulatory Affairs

28