5 Tips for Planning an Investigator Meeting

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

An Investigator Meeting is a time for everyone involved with a new clinical trial to meet face to face and get familiar with the study, including learning about the roles in the study. This is essential for building and maintaining solid communication throughout the entire duration of a study, as it keeps the study on a more personal level. When a sponsor initiates an Investigator Meeting, depending on the size of the company, they may look to internal staff to plan an Investigator Meeting. In other cases, companies may invest in a third-party vendor that specializes in events to handle the logistics. But whether you’re planning an event for an in-­house company team, a third-party company, or even a wedding, the following tips will help any event planner navigate an event to success!

1. Where does an event planner even begin for an Investigator Meeting?

You will need to know from your client as much detail as possible: all the who, what, where, when, and how for the meeting; specifics like who are the required attendees, what is the outline meeting agenda, where will this meeting be held, when does the meeting need to happen, and how much is in your client’s budget for the entire meeting. You must also determine if the client requires having an event coordinator on site during the entire meeting. These questions may seem basic, but this is the foundation you’re building that also serves as defining the scope on your level of involvement in planning the event.

An important thing to have is an overall agenda for the entire meeting, including any special events that operate outside of the actual meeting itself that attendees are expected to attend. This information allows you to connect with potential venues to reserve space for specific portions of the Investigator Meeting and informs attendees for planning travel dates.

2. The attendees are starting to arrive, now what?

A group email announcement to the attendees, outlining the key details that they will need for their arrival, should be sent well in advance of their arrival time/day. This will allow the attendees enough time to receive and review the information before boarding a flight, and is a great opportunity to send out the overall agenda to the attendees as well! As a personal, yet important touch, send an email to each attendee with their specific travel information, including flight and hotel confirmation numbers, and suggest transportation services that are available once they arrive. Be sure to let them know who to contact upon arrival.

If you have been the main point of contact throughout the meeting, be prepared to facilitate some broad questions or requests from the attendees that may not seem like your area of expertise or within the scope of work for this event. This could include anything from questions on where to send expense reports after the meeting concludes, running errands for an attendee, or even rearranging furniture at the venue.

Most likely there are going to be some key speakers who do not present to a crowded room very often. It’s a good idea to print their presentation for them in case they lose track, or the computer logs off for some reason. Have the speakers come in before the meeting begins and do a sound check to hear their voice. This will help to prepare them for their presentation. It is especially helpful if you are using a lavalier, as some people may get a little nervous and not project loud enough resulting in a muffled presentation.

3. Will those last-minute changes ever end?

Obtaining the final versions of meeting materials can seem like an uphill battle. Building and finalizing the meeting materials usually resides with the client, but the event coordinator will need to know if all materials are finalized and if copies need to be made available to attendees at the meeting either electronically (preferably) or hardcopy. Set a strict deadline for when materials need to be finalized to ensure that they get sent to attendees ahead of the meeting and are printed (if needed).

It’s also worth mentioning that content from the meeting can be made available to attendees through many different platforms, and using email is not the only or best method for getting materials to attendees.

4. There’s no I in team…

Delegation at any event is key because it’s impossible for one person to be in multiple places at once. If having a secondary coordinator on site with you is not an option and you need to figure out how to be in two places at once, alert your client to this and see if they could tap someone on their team to step in for temporary assistance.

If you are working with a travel agency who is booking flights for the meeting, ask the travel agent to copy you on the generated itineraries. You’ll stay one step ahead with having a copy of the itineraries should any of your attendees have trouble remembering when they arrive and depart! The itinerary is also a great item to have on hand when submitting the final list of names and reservation dates to the hotel.

5. Always room for improvement, right?

Print-outs at a meeting can be a bit of an issue. Often the printouts are discarded immediately after the meeting, ending up in the trash can. If there is a need for attendees to have full access to all of the meeting materials, look for ways to reduce paper waste by urging attendees to utilize electronic methods first. Not only is this a huge cost saving because printed materials prepared at the last-minute cost more, but it is also an area of events management that has a sizable environmental impact. Choosing electronic methods over paper printouts is an opportunity to reduce not only costs, but also post meeting waste.

Another potential cost saving area is to forgo an expensive hotel chain for a meeting venue. Try finding a meeting venue that supports locally owned businesses. Guests can stay at the hotel, but holding a meeting at an off-site location gives attendees the chance to explore the city. Why go through all the trouble of flying attendees in, to have them only see the inside of a hotel at an airport?

While I could easily write a novel on everything involved with event planning for meetings, hopefully these tips will help you get started with planning your next event, whatever the occasion!

Information for this article was contributed by Valerie Crossley, an Associate at myClin, who is an experienced project manager in Medical Affairs clinical trials and as an event planner for a wide variety of event types ranging from larger executive level corporate events to weddings.

By Valerie Crossley, Office Associate & Project Manager at myClin

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