Presentation content refers to material that a medical representative shows in hand while explaining a product to healthcare professionals. It covers not only printed visual aids but also digital material run on a tablet. In front of every page or screen there is always a person doing the talking, and spoken commentary is layered on top. That single fact sets this material apart from every other kind. For that reason the Creation Guide states at the outset that the intent of Chapters 1, 2, and 3 carries over directly into this format.
This page interprets Part III, Chapter 1, "Presentation Content," of the Creation Guide in light of the spirit of the foreword and the discipline of science. It does not reproduce the source provisions; it reconstructs their intent. Actual material must be checked against the latest package insert and the original text.
01Why "material with a presenter" gets its own chapter
The foreword is the constitution of the whole Guide. It states plainly that the basis of proper-use information is the package insert, and that product information summaries and the like sit in a "supplementary" position to it. The word "supplementary" is not light. What supplements cannot exceed what it supplements. Against the original — the approved content — material may not step one character beyond the approved scope. Presentation content is no exception.
So why a separate chapter? The reason lies in the nature of the medium. Slides are turned one at a time, the presenter's words layer over them, and the listener forms an impression on the flow of the moment. Material that remains as continuous text can be reread and surveyed as a whole, but presentation content is dominated by "the one page on screen now." Through the combination of order, emphasis, and spoken commentary, a written fact can stay factual yet still create a mistaken impression. The foreword's other implication — that the duty not to lie and the duty not to mislead are two different things — is tested most sharply here.
"Everything is written within the approved scope" is not enough. A structure that shows one page at a time can produce a mistaken overall picture from correct numbers. The correctness of facts (the duty not to lie) and the correctness of impression (the duty not to mislead) must be checked separately.
02Guaranteeing the efficacy–safety balance through structure
Efficacy lined up everywhere, safety reduced to a footnote — this is the bias most likely to arise in presentation material. The Guide does not leave it to the writer's conscience; it binds it through structure. It requires that efficacy and safety be balanced across the content as a whole, and that safety (results) be set out as an independent item, made at least as prominent as efficacy (results).
The asymmetry of "at least as prominent" is the point. It is an expression of the foreword's duty to disclose safety even when it is unfavorable to one's own product. Efficacy invites being told; safety invites being held back — and to cancel that natural slope, weight is deliberately placed on the safety side. Specifying matters down to the level of appearance — font size, item independence, placement — turns "accurate and not misleading" into an operable rule.
Do not over-emphasize through visual effects
Truncating a graph axis, playing up a difference with arrows, making only one part stand out with color or bold — such staging manipulates impression without changing a single figure. Because presentation content can even use animation and screen transitions, the room for exaggeration is wider than on paper. Hence the explicit brake: "do not over-emphasize through visual effects." Think of it as Chapter 1's foundational discipline — "no convenient extraction, no emphasis by color or bold" — read across to the medium of the screen.
| Issue | A presentation that invites misreading | What the Guide requires |
|---|---|---|
| Treatment of efficacy and safety | Efficacy-centered, safety small and in the margin | Safety as an independent item, at least as prominent as efficacy |
| Expressing a difference | Between-group gap played up with arrows, scaling, color | Results presented plainly as fact |
| Reference information | Shown from the opening, placed at the center of the material | One-quarter or less of the whole, marked as reference on each page |
03If you state a feature, keep the basis inside the same content
If a product's features are described, the supporting data must be shown within the same content. Saying "it is superior" out loud while leaving the basis in a separate document makes verification impossible. If clinical results are included, the design of that trial — subjects, methods, the positioning of endpoints, and so on — must be stated alongside. The source is to be noted on each page (each slide): the state of affairs must always allow tracing "where the number on this one page came from."
This connects directly to one of the foreword's three pillars — guaranteeing verifiability through structure. Material may not remain in hand once the explanation is over. Precisely for that reason each single page must carry its own source. Where the company is involved in a trial, the conflict of interest (COI) is recorded in the trial-design section or the like. Not hiding who funded a trial is part of honesty.
Why stating the trial design is mandatory
Even the same "statistically significant" carries entirely different weight depending on whether it is the result of a pre-specified primary endpoint in a double-blind confirmatory trial, or a nominal p-value pulled from a post-hoc subgroup. The former supports a conclusion; the latter is only the entrance to a hypothesis. A slide that omits the design strips this distinction from the listener. So stating the design is not decoration but the premise for reading the number correctly.
Same data, different impression. Showing "significant on the primary endpoint" on a single slide differs from showing "significant, confirmatory, under double blinding, on the single pre-specified primary endpoint." The certainty the listener takes away changes. Only the latter conveys the weight the number actually deserves.
04Quarantining reference information — never at the center
Reference information means results obtained secondarily within the approved scope, or findings whose relation to efficacy is not necessarily clear. It can be useful, but it differs in character from the principal basis of approval. Make it the lead and the listener mistakes it for the approved efficacy itself. So the Guide fences reference information tightly even in presentation content.
- Keep reference information to one-quarter or less of the whole content. Preserve the hierarchy by volume.
- On each page that carries reference information, state clearly that it is reference information.
- Do not open with reference information. Do not make a piece centered on reference information.
- Do not attach a supervisor's comment to reference information — so that information treated as reference is not elevated by a third party's authority.
The one-quarter ceiling is aligned with the treatment of reference information in Part I, Chapter 3 (item-specific product information summary). The idea running through the whole Guide — protecting the hierarchy through volume and placement — stays consistent even when the medium changes.
Make the DI easy to consult
Presentation content is a place to show summarized information, not a place to cover the full caution information. So a path that reaches the product information (DI) quickly — on a tablet, a link or a jump to the relevant page — must be prepared. Being able to return to the package insert, the original of approval, at any time: that is the minimum condition for implementing the "supplementary" position.
05What must not be made in this format
The Guide defines what must not be made in this format just as firmly as what may be made. Conference-abstract collections and literature-abstract collections must not be made in the form of presentation content.
The reason lies in the origin of the material. Conference-abstract and literature-abstract collections are by nature passive material provided "in response to a request" from healthcare professionals, and pushing them onto people is to be avoided (this is set out in detail in the later chapters of Part III). Dress them up as presentation material that a representative actively explains on rounds, and the passive character collapses; the premise of "responding to a request" is hollowed out. Borrowing the look of a medium to swap its character — this falls into the same pit as the notion the foreword shut down: "if it isn't in the manual, it's free." So it is prohibited at the entrance.
Borrowing a format changes the very character of the content. Shifting "material provided in response to a request" into a format that a presenter actively shows breaks the restraint that material is meant to keep. The choice of format is itself part of the discipline.
The core of presentation content comes down to facing the nature of the medium. Pages shown one at a time, with a person adding words — because of this strong influence, not only the correctness of facts but the correctness of impression is in question, and the efficacy–safety balance is structured down to the level of appearance.
Keep the basis inside the same content, the source on each page, reference information quarantined to one-quarter or less, and the DI always within reach. And do not divert abstract collections, which should be passive, into this active format. Each of these is the consequence of translating the foreword's spirit — the package insert as the original, "accurate and not misleading," "in a verifiable form" — onto the medium of screens and slides.