Biopharmaceuticals (includes Biologics)
The session will provide regulatory professionals with practical information they can use to be more effective in their regulatory preparation. They can use the information to help them set realistic timelines, choose the best core presenters and team members, plan and conduct effective mock meetings, utilize-technologies to improve the preparation and maximize the Open Public Hearing. Based on years of experience and feedback from former and current regulators, we will also provide practical information so they can create an effective briefing book and core presentation, slides that better convey their messages. They will also be able to conduct a Question and Answer Bootcamp to prepare their team. For the CHMP Oral Explanation some of these processes are similar - e.g., Question and Answer Bootcamp – while some are different – e.g., there is no Open Public Hearing. Understanding the similarities will help them better advise their team so they can conserve efforts and leverage the materials and resources that are common between the two meetings. Understanding the differences will help teams plan efficiently for simultaneous or consecutive meetings.