Life sciences companies rely on speakers to educate HCPs about their products. These presenters — often esteemed KOLs in their respective fields — are an invaluable link between clients and the medical community; as such, these relationships come under a higher degree of regulatory scrutiny today than they might have in the past.
Managing speakers is a multifaceted and complex process: They need to be regularly updated and trained on the material they will be presenting for educational as well as compliance purposes, and all expenses and payments associated with those efforts need to be meticulously gathered and documented, even when they cross disciplines, business units or geographic borders.
Training can take place for many reasons: New therapies are introduced all the time, and HCPs need to be kept abreast of these innovations, as well as developments pertaining to the use and applications of existing products. Training can be as simple as a brief update conducted virtually to a weekend-long intensive curriculum covering a wide swath of knowledge.
Speaker messaging is of utmost importance: Speakers need to be trained to know all aspects of approved pharmaceutical uses for the product on which they are educating HCPs, and — more importantly — they need to know the limits of those uses. If a speaker recommends a drug for an “off label” use while acting at the behest of a life sciences client, that client can be open to penalties.
Therefore, it is imperative for companies to know with absolute certainty that their speakers have received the training they need. Verifying this takes different forms, depending on whether the training takes place virtually or in-person. In-person sessions require real-time badge-scanning to verify that trainees are in attendance, while virtual training uses sophisticated tracking technology for both voice and web connectivity to verify participation.
This all sounds — and is — complicated, but government regulations to which life sciences companies must adhere requires them to track and collect all this data, and more. Since speakers are compensated for their time and services, the “Sunshine Act” mandates that life sciences companies must report on all transfers of value to speakers undergoing training, a requirement that encompasses everything from honoraria to travel expenses and the cost of meals served during face-to-face training sessions.
Creating and executing compliant speaker training isn’t an insurmountable challenge, but it is daunting for a company whose core competency lies in lifesaving medical devices or critical drug therapies — not logistics, analytics or technology — to do so seamlessly and cost-effectively.
As the pace of pharmaceutical advancement continues to accelerate, more firms are electing to partner with experienced providers of technology, communications and event management. The value proposition these firms offer is ensuring that compliance issues don’t ensnare the content delivery apparatus that informs and educates HCPs throughout the industry.