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Regulatory Focus™ > News Articles > 2020 > 4 > Preparing for virtual regulatory meetings

Preparing for virtual regulatory meetings

Posted 16 April 2020 | By Jim DiBiasiCindy DiBiasi 

Preparing for virtual regulatory meetings

This article discusses how sponsors can prepare for their meetings with regulators in light of the recent FDA and EMA announcements that Advisory Committee meetings and Oral Explanations—as well as other “essential” regulatory meetings—will be conducted virtually. While this article specifies Advisory Committee meetings and Oral Explanations, the need for preparedness and tools described also applies to any virtual meetings that are held with health authorities.
 
Introduction

It may be hard for us to think of anything but the coronavirus right now. While many pharmaceutical, biotech and medical device companies are focused on developing COVID-19 tests, treatments and vaccines, there are thousands of teams working on non-COVID-19 products. Many of these therapies are also life-saving.

With FDA announcing they will hold virtual Advisory Committee meetings for some sponsors, as well as other virtual “essential” regulatory meetings, (EMA made a similar announcement in March), many companies are scrambling to prepare for this new reality. FDA has acknowledged the meetings would require more planning from their team. You can be sure that the same is true for companies that will be presenting virtually before these regulatory bodies.

The reality is that communicating effectively is just harder to do in this virtual meeting environment. But with PDUFA and MDUFA deadlines looming, business targets to meet and the urgency of getting their important treatments to patients—companies are preparing for virtual meetings with regulators. The challenge is how to do it effectively.

Before and after COVID-19

Before COVID-19, many meetings between companies and regulatory agencies were conducted by teleconference. But there was an important difference between those virtual meetings and the ones taking place today. Before COVID-19 most, if not all, of the company team was taking the call in the same room. That meant team members could immediately put the telephone on mute during the meeting to quickly confer on strategy or project a slide or data. Now, they must find a way to do this with team members in different locations. Not surprisingly, the key to succeeding at this in a virtual environment is the right planning, the right technology and the right practice. And virtual meetings are even more difficult for FDA Advisory Committee meetings and CHMP Oral Explanations, where there are many more stakeholders and participants involved.
 
Private communication among team members is critical

Starting with planning: companies should have clear roles for each team member and decide in advance who on their team will speak and when. During the meeting, they need a system to signal when a team member wants to say something, and identify in real time what, if any, slides to show in answer to regulators’ questions.

Next, it is essential to run full rehearsals to make sure everyone knows how to execute on the day of the meeting. Rehearsing is critical because it’s often the little things that unravel a virtual meeting.

A key to success in virtual meetings is having the right technology system. And it’s not just Zoom. The best systems are a combination of proprietary tools and proven third-party virtual meeting software. These systems enable the moderator to instantly get a slide with data when answering a regulator’s question and importantly, be able to privately preview it before projecting it to regulators. This requires having multiple lines of communication during the meeting—one to project slides or data—a parallel system allowing teams to privately and quickly communicate with the speaker and with each other—and the direct line with the agency.

Just having the right technology isn’t enough. Virtual meetings bring with them an extra layer of complexity. Given all the other things company teams must accomplish during a regulatory meeting, they should take tech concerns out of the picture. That means a technology professional should run all tech during the practice and the day of the meeting. A professional can advance the slides and control the display of backup slides and enable the multiple technology threads simultaneously to accommodate the split-second private communications the team might need in order to be responsive to questions.

Preparing for “the big show”

FDA advisory committee meetings and CHMP oral explanations

FDA Advisory Committee meetings and CHMP Oral Explanations are considered “The Big Show” in regulatory parlance. These meetings have always been held face-to-face—with Advisory Committee meetings also being open to the public.
 
Last month, CHMP started to hold virtual Oral Explanations. FDA is already notifying companies privately that they may have the option of going to a virtual Advisory Committee meeting. Where does that leave company teams? They must conduct their preparations virtually and they must prepare for a virtual meeting. In this case, all the above guidelines apply—but preparation and execution are much more complex.
 
The biggest difference is the stakes. Advisory Committee meetings and Oral Explanations are usually convened because the product or issues around them are more complex and controversial; regulatory agencies believe they need expert advice to make a decision for, or against, approval. For Advisory Committee meetings, an extra layer of exposure is that the meetings are open to the public—by law. That will continue in a virtual environment.
 
Preparation for these meetings hinge on rigorous preparation and practice for the team. They must replicate the same realistic mock meetings they may have been used to doing in a face-to-face, but now on a virtual platform. That means both the company team and the mock participants (external experts who mimic the regulators teams will be facing) need to be proficient in a virtual world. Companies should conduct a complete process and technology rehearsal with all the mock participants the day before the rehearsal so each external expert can make sure their internet connections, computers and technology are working, and that they know how to use them. It’s also important to have a clear and orderly process for the participants to ask questions of the company presenters—just as FDA Advisory Committee and CHMP members will—and when the rehearsal is over, to be able to provide immediate feedback.
 
Communications “basics” still apply

Along with the new procedures to excel at virtual meetings, companies need to remember the same communications “best practices” they carried out for face-to-face meetings. If the meeting requires a formal presentation, presenters should script their presentation, test their content and delivery, identify the most likely challenging questions and develop credible, convincing answers.

Providing regulators with the right answer, the right data and the right slide under pressure in a virtual setting may be more complicated—but with focused training and appropriate technology, they can be successful. At the end of the day, that is a win for the companies, for public health and for the patients waiting to get these important therapies.

About the Authors

Jim DiBiasi, co-founder of 3D Communications, has guided more than 100 companies through high-stakes regulatory interactions—providing strategic and tactical communications counseling. He also coaches top executives, scientists and doctors in the pharmaceutical, biotech and medical device industries. DiBiasi is known for his ability to lead diverse teams and help them achieve their goals at decisive communications opportunities. As a co-founder of 3D Communications, he has been instrumental in developing the company’s proprietary processes, practical tools and innovative technology—all which have been built specifically to drive clear communications in both face-to-face and virtual FDA and EMA regulatory meetings. He can be reached at jdibiasi@3dcommunications.us.

Cindy DiBiasi, co-founder of 3D Communications, has built a reputation as a leading healthcare communications consultant, working with top executives at some of the world’s largest companies. Her strength is helping companies translate complex scientific and health economics information into interesting and relevant messages—and then coaching executives to clearly and confidently deliver that information in the face of objections. DiBiasi is a board member of the Consumer Healthcare Products Association (CHPA.) She has a Master’s degree from Boston University, Paris. She can be reached at cdibiasi@3dcommunications.us.

3D has authored two chapters on preparing for EMA meetings in the upcoming 9th edition of RAPS Fundamentals of EU Regulatory Affairs, scheduled for publication in June 2020.

Cite as: DiBiasi J and DiBiasi C. “Preparing for virtual regulatory meetings.” Regulatory Focus. April 2020. Regulatory Affairs Professionals Society.
 
 

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