NEED n Approached by Japanese pharmaceutical company with an antiviral product intended to treat and prevent influenza, seeking approval for proof-of-concept (PoC) efficacy clinical study n Assistance required for interactions with European agency to ensure efficient review of protocol and general clinical development plan APPROACH n Reviewed non-clinical data and non-clinical development program n Prepared briefing package for scientific advice meeting with national European agency n Liaised with European agency and ensured timely submissions for scientific advice meeting n Coordinated European agency meeting with the client and managed all oral and written communications between the Japanese client and European agency BENEFITS n Extensive review of all

Join for free to read