Session Title: Don’t Blow Your Big Chance: How to Win with FDA and EMA Regulators

Robert Seevers, Senior Advisor at Pearl Pathways, will speak during this session and participate in the panel discussion as an expert on the topic. 

Session synopsis: 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. Learning Objectives:

• Determine what deliverables will be needed for an FDA Advisory Committee / Panel meeting and a SAG / CHMP Oral Explanation.
• Prepare and maximize the team’s time for an FDA Advisory Committee / Panel meeting and for a SAG / CHMP Oral Explanation.
• Construct appropriate timelines for an FDA Advisory Committee / Panel meeting and a SAG / CHMP Oral Explanation.

Date: Tuesday, September 24

Time: 10:30 – 12:00pm EDT

Location: 201 C

Robert Seevers will also speak during a “Solutions Circle” on Monday, September 23 from 12:15 – 12:45pm at RAPS Central in Exhibit Hall A. Seevers’ presentation will cover “What to Do During Those ‘Oh No!’ Moments: Questions from Regulators.”

We look forward to meeting you at the 2019 RAPS Regulatory Convergence conference! Pearl Pathways will be located at Booth #400 in the exhibit hall.