Oral Explanation Preparation
An Oral Explanation can determine the fate of your product.
An Oral Explanation (“OE”) is one of the last opportunities you have to overcome any major objections the CHMP may have about your product.
We support applicants throughout the MAA process, developing strategy, creating a regulatory roadmap, and providing overall submission support. Our team provides independent and strategic insight into how best to address the scientific concerns of the regulators in writing. Of course, the best way to prepare for an Oral Explanation is to avoid having one in the first place! That means crafting the strongest possible 120 Day Responses.
NDA’s scientific and communications experts will review and refine those responses. The goal is to address any issues in writing but also lay the groundwork should you need to support your position in person at an Oral Explanation.
An OE defines “high-stakes”: Time is tight, and you’re expected to provide a clear, concise and targeted response to major objections of the CHMP. NDA/PharmApprove helps your team prepare to win.
Why choose us for this service?
We have prepared hundreds of teams for challenging regulatory interactions in Europe and have developed a highly effective process that quickly enables internal teams to focus on what is most critical. Our service offerings include:
- Disciplined meeting management
- Development of a compelling presentation
- Intensive rehearsal “in role”
- Wide ranging Q&A response rehearsal
Our process is adapted from the highly successful approach that we’ve taken to Advisory Committee preparation in the United States, where over 80% of our projects have resulted in positive votes.
How can we support you?
Our Strategic Leads, ex-regulators and scientific communications coaches work together to support your team. We will analyze the issues, pressure test responses and prepare your team to deliver convincingly.
We offer a full range of OE preparation services:
- Messaging strategy
- Presentation development, including script and slides
- Scenario planning
- Presentation coaching for presenters and responders
- Q&A drills
- Experts to pressure testing content and strategy