CHMP Meetings: A Rare Behind-the-Scenes Look at These Private European Regulatory Meetings
The first thing you need to know about CHMP meetings is that they are not public.
Because of this, you can’t research these extremely high-stakes meetings by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.
Since 3D has prepared many clients for CHMP meetings, we are often asked to describe what goes on behind the closed doors – and how to effectively prepare for these meetings. In this blog, we’ll focus on taking you behind the scenes. In our next blog, we will look at what you should do to prepare for your meeting and steps to succeed once you’re in the room.
Let’s start with some background. Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) is the group that reviews scientific data and recommends marketing authorization – or not. Two CHMP representatives, a primary “rapporteur” and a supporting “co-rapporteur,” are charged with analyzing the applicant’s data and making recommendations to the agency. The CHMP may also seek scientific or risk management advice to inform its decision and/or discuss objections. Finally, the CHMP may convene a meeting to discuss disagreement between the rapporteurs or between the rapporteurs and the applicant on specific topics.
While there are several types of meetings, we’re going to focus on the most common – the CHMP Oral Explanation, or OE. The OE is convened at the end of the CHMP review cycle to decide on marketing authorization. It is attended by representatives from each EMA member nation who are asked to debate and vote on issues specific to the benefit-risk of the product. Ultimately, the applicant seeks to resolve the remaining CHMP objections. A positive vote by the panel can mean the difference between product approval or the need for additional data. Now that you have the background, let’s dive deeper into the challenges that await applicants at an OE.
First, since the meetings are held behind closed doors, even the applicant is not present for much of the discussion. The rapporteurs typically make their own presentation before the applicant is even allowed in the room. So, when applicants present and answer questions, they don’t know what the panel has already heard. In addition, applicants have only one hour to present their data AND answer the panel’s questions – basically a 20-minute presentation and then 40 minutes of Q&A. In addition, applicants are usually not allowed to have more than ten people in the room. This means the applicant must field tough Q&A without much backup from internal or external experts. To top it off – CHMP runs the presentation and Q&A off a single PowerPoint file. Because of this, many sponsors will only include a few backup slides to address questions. That means that most questions are answered verbally without slide support.
After the hour is up, the applicant is dismissed so the CHMP can deliberate – and vote – in private. The rapporteur then meets with the applicant to convey general conclusions and deliver vote results and recommendations. Clearly, a set up that is not conducive to applicants being able to take control should issues arise.
The good news is that there are ways to overcome these challenges. In our next blog, we will talk about the new processes and technology tools applicants can use to have more control at these important CHMP meetings.
ABOUT THE AUTHORS
Penny Daniels is a strategic communications consultant and coach for pharmaceutical and device companies, academic institutions, government, and non-profits. As an accomplished writer and former national broadcast journalist, Penny uses her expertise to help 3D clients communicate effectively in challenging environments, including FDA Advisory Committee meetings. Penny excels at empowering communicators to optimize their own individual styles to meet audience needs and achieve business and organizational goals. Connect with Penny on LinkedIn.
Kell Cannon brings more than 20 years of U.S. and global lifecycle and pharmaceutical marketing expertise to 3D’s clients. Kell has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA Advisory Committee presentations. This assistance enables companies to win approval, expedite product access, and achieve competitive reimbursement. Connect with Kell on LinkedIn.