By: Partha Roy, VP-Technical and Catherine McHugh, Senior Director, Parexel Regulatory & Access
Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to social distancing restrictions in response to the global pandemic, Health Authorities have done the same. In fact, the U.S. Federal Drug Administration has issued new guidance1 for conducting formal meetings via videoconference, stating, “At this time, all meetings will be held virtually.” Health Authorities in China, the UK, Europe and Japan are moving in the same direction.
Fortunately, technology today allows us to do that. And in many ways, nothing has changed. You still need to achieve successful dialogue with the health authorities to optimize development. Let’s look at the preparation that entails.
To start, the team must clearly establish the meeting objectives based on the product roadmap and stage of product development. The meeting request letter, with multi-disciplinary questions, is prepared to initiate efficient exchange of information around the most relevant and challenging drug development and regulatory issues. The background package, containing careful presentation of background information and relevant data, is sent well ahead within the specified timelines. The meeting is meticulously planned, with the functional subject matter experts chosen to attend, the sequence of topics determined and presenters rehearsed well in advance.
Typically, the Health Authority provides preliminary responses to the questions ahead of the meeting. Topics for discussion, company positions and responses to Health Authority questions are confirmed and background information distributed to all attendees. Note that preliminary responses serve as a foundation for discussion or evolve into the final meeting responses. The ability to interpret preliminary responses, “reading between the lines,” is critical for an efficient dialogue that will properly map the development path. This involves determining the points of agreement and uncertainty and understanding opportunity for negotiations.
That said, this virtual format introduces a challenging new set of demands, from technology infrastructure to managing human behavior. How can meetings simulate the in-person experience and promote effective collaboration to deliver the desired regulatory outcomes? How can meetings be conducted efficiently and professionally to make a seamless transition to the virtual space?
As plans and preparations are being put in place, we recommend that you evaluate technical requirements in parallel, well in advance. Some requirements are a given. For example, the meeting must be run on a highly secure platform to support a free exchange of proprietary information and prevent interruptions, whether of a technical or malicious nature.
The platform should support other functionalities, depending on the meeting objectives. These might include whiteboarding, breakout sessions, real-time document editing and slide presentations. One important element not to overlook is live chat, which enables attendees to communicate during the meeting, whether privately or to the group. Has a colleague forgotten to mention an important point, or seem to be losing focus? Live chat can be an essential tool, absent the ability to read body language or to politely interject – both normal behavior in a face-to-face session.
Keep in mind, too, that the designated moderator should have experience in facilitating a virtual meeting, skilled in understanding how to move the discussion along efficiently and diplomatically without the benefit of eye contact and other nonverbal cues.
Something else to consider when deciding on a technical platform is the number of people it can support. You can think big. In a traditional in-person meeting, the number of attendees from the sponsor’s side is limited by logistical considerations – namely, travel budget. A virtual meeting, on the other hand, accommodates many more attendees, creating an ideal opportunity for junior staff or lab specialists to sit in. They can simply listen on mute, on camera or not, without creating the perception of too many people in the room. From a professional development standpoint, this experience can be invaluable.
Virtual meeting etiquette
This brings us to the discussion of virtual meeting best practices. Part of the meeting preparation and rehearsal should cover etiquette basics. For presenters, pre-meeting coaching is essential. Presenters should rehearse speaking slowly and clearly, and understand when to go on mute, how to use the “raise hand” function, and how and when to interject a comment (or not).
Of course, most attendees will be using a video camera. The great majority are likely to be calling in from home, and many will need to figure out how to prevent distractions –dogs barking, phones ringing, teenagers wandering past. Even if calling in from the bedroom, the attendee should be wearing appropriate business attire, the backdrop should be professional, and the camera should be adjusted at the proper angle. All attendees should call in 15 minutes early for a final check and fine-tuning.
With this thorough preparation, the meeting execution will take care of itself. As soon as possible after the meeting concludes, the internal group should meet for a debrief, comparing notes and aligning interpretations. One attendee or a small team then takes charge of drafting detailed meeting minutes to be agreed upon and sent to the Health Authority.
The right partner for first-hand expertise
One final note: we cannot overemphasize the importance of choosing the right partner to support you in planning and executing these crucial meetings. Parexel is ideally positioned to do that. With more than 80 former regulators on staff, we know how these professionals think – because we’ve been there. We know exactly how to navigate the shifting regulatory landscape and understand the expectations of regulators in these tumultuous times. With our support, you can create that “in-room” experience virtually – so vital, because getting it right within the limited scope of time and attention from the regulators is paramount. Patients are waiting for your breakthrough.
Download our factsheet to learn more.
1 Effects of the COVID-19 Public Health emergency on Formal Meetings and User Fee Applications – Questions and Answers, U.S. FDA, May 2020.