| # | Module | What it covers | Content |
|---|---|---|---|
| Week 0 — Scientific English | |||
| 0.1 | Where is your English actually weak? | An 8-question rapid triage that diagnoses the 4 core English habits costing you manuscript acceptances and interviews —… | — |
| 0.2 | Articles: a, an, the, and nothing | The single largest error class in Indian scientific English — and the one that never clears by itself, because your… | 3 quiz · 1 drill |
| 0.3 | Tense: the IMRAD tense map | Scientific English uses tense to signal how certain a statement is. Get it wrong and you accidentally claim more — or… | 2 quiz · 1 drill |
| 0.4 | Register: hedging, claims and Indianisms | The unit that separates a competent writer from an employable one — calibrating how strongly you claim, and removing… | 2 quiz · 1 drill |
| Week 1 — The pharma universe | |||
| 1.1 | The day a drug is born | From a molecule in a laboratory to a medicine in a patient's hand — the journey that creates the industry you are… | 1 quiz |
| 1.2 | Who does what in pharma | The people inside the pipeline — their roles, their documents, and where you fit among them | 1 quiz |
| 1.3 | ICH-GCP — the rulebook | The guidelines that govern every clinical trial on the planet — and why you must know them before you write a single… | 1 quiz |
| 1.4 | Career paths — your map | Where you can go from here, how fast, and what each path actually looks like from the inside | 1 quiz |
| Week 2 — Scientific writing | |||
| 2.1 | IMRAD in depth | The universal structure of all scientific writing — and how to master each of its four sections | 1 quiz |
| 2.2 | Literature search mastery | How to find, filter and organise the evidence that every document you write depends on | 1 quiz |
| 2.3 | Abstract writing clinic | The 250-word document that gets your paper published, your poster accepted, and your career started | 1 quiz |
| 2.4 | Reading clinical data | How to interpret forest plots, Kaplan-Meier curves, hazard ratios and p-values — without being a statistician | 1 quiz |
| Week 3 — Pharma documents | |||
| 3.1 | MSL slide decks | The document that bridges scientific evidence and medical practice — and one of the first things you will be paid to… | 1 quiz |
| 3.2 | Clinical study reports (ICH E3) | The backbone of regulatory submissions — demystifying the 340-page document and mastering Section 9 (Methods) | 1 quiz |
| 3.3 | Regulatory writing | The highest-paid specialisation in medical writing — and the field growing fastest in Indian pharma | 1 quiz |
| 3.4 | Patient information leaflets | Writing for patients — the hardest audience, the most important document, and the one most medical writers underestimate | 1 quiz |
| Week 4 — Industry readiness | |||
| 4.1 | Pharmacovigilance basics | The science of drug safety after approval — and why medical writers are essential to the entire system | 1 quiz |
| 4.2 | Biostatistics for writers | You do not need to run the statistics. You need to read them, understand them, and write about them without error | 1 quiz |
| 4.3 | AI in Medical Writing: The Four Obligations | Every earlier module in this course taught you to produce a document. This one teaches you to be accountable for one… | — |
| 4.4 | Freelance and career launch | Everything you need to earn your first rupee from medical writing — and build a sustainable career | — |
| 4.5 | Choose your professional pathway | You have surveyed the landscape of clinical research and medical writing. Now it is time to choose where you go deep —… | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Diagnosis and core errors | |||
| 1.1 | Where is your English actually weak? | A 24-question diagnostic that finds the specific error patterns costing you interviews and manuscript acceptances — and… | — |
| 1.2 | Articles: a, an, the, and nothing | The single largest error class in Indian scientific English — and the one that never clears by itself, because your… | 3 quiz · 1 drill · 1 fig |
| 1.3 | Tense: the IMRAD tense map | Scientific English uses tense to signal how certain a statement is. Get it wrong and you accidentally claim more — or… | 2 quiz · 1 drill · 1 fig |
| 1.4 | Subject–verb agreement under pressure | You know the rule. You break it anyway — because scientific sentences put fifteen words between the subject and its… | 3 quiz · 1 drill |
| Week 2 — Nouns, prepositions, structure | |||
| 2.1 | Countable and uncountable nouns | The s that must never appear — and the counting words that let you say what you actually meant | 3 quiz · 1 drill |
| 2.2 | Prepositions and fixed verb patterns | No rules, no logic, no shortcuts — but a short list of pairings that covers almost everything you will write in… | 3 quiz · 1 drill |
| 2.3 | Word order and modifier placement | Where you put a word decides what it modifies. In clinical writing, a misplaced only or a dangling participle is not… | 3 quiz · 1 drill · 1 fig |
| 2.4 | Punctuation for scientific text | Six marks, used properly, cover everything you will write — and one of them, the hyphen, is the fastest way for a… | 3 quiz · 1 drill |
| Week 3 — Precision and register | |||
| 3.1 | Concision: cutting a quarter of your words | Journals cap abstracts at 250 words and regulators cap nothing but read everything. Learning to cut 25% without losing… | 3 quiz · 1 drill |
| 3.2 | Hedging and claim calibration | The most commercially important unit in this course. In scientific and regulatory writing the verb you choose is a… | 3 quiz · 1 drill · 1 fig |
| 3.3 | Register and Indianisms | Correct English that costs you the job — the administrative vocabulary that marks a draft on sight, and how to match… | 3 quiz · 1 drill |
| 3.4 | Parallelism and cohesion | Individually correct sentences that do not hold together as a paragraph — why your Discussion reads as a list of true… | 3 quiz · 1 drill · 1 fig |
| Week 4 — Convention and application | |||
| 4.1 | Numbers, units and abbreviations | The conventions that make a draft look professionally edited — small, mechanical, entirely learnable, and the first… | 3 quiz · 1 drill |
| 4.2 | The sentence clinic | Eleven units of rules, applied one sentence at a time. This is where recognition becomes production | 3 drill |
| 4.3 | The abstract clinic | Moving from the sentence to the paragraph — where tense, hedging, cohesion and word limits all have to be satisfied at… | 1 drill |
| 4.4 | Capstone and exit assessment | A full manuscript section, thirty seeded errors, no category labels — and an honest measure of whether four weeks… | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Foundations | |||
| 1.1 | Statistics diagnostic | Twenty-four questions covering everything a medical writer is expected to read, interpret and describe correctly — and… | — |
| 1.2 | Data types and descriptive statistics | Which summary belongs with which kind of data — and why reporting a mean for skewed survival data is the most common… | 3 quiz · 1 drill · 1 fig |
| 1.3 | Sampling, uncertainty and confidence intervals | Why every number in a trial is an estimate, what a confidence interval actually claims, and how to describe precision… | 3 quiz · 1 drill · 1 fig |
| 1.4 | The p value | The most misused number in medicine — what it measures, the four things it does not, and how to write about… | 3 quiz · 1 drill |
| Week 2 — Comparing groups | |||
| 2.1 | Hypothesis testing, power and multiplicity | Why sample size is fixed before the first patient is enrolled, what 80% power actually promises, and why testing twelve… | 3 quiz · 1 drill |
| 2.2 | Choosing and naming the right test | You will not select the test — but you will describe it in Methods, and naming the wrong one is a QC finding. A… | 3 quiz · 1 drill |
| 2.3 | Effect measures: RR, OR, HR and NNT | Four ways to express the same benefit, three of which are routinely described in language that belongs to one of the… | 3 quiz · 1 drill · 1 fig |
| 2.4 | Reporting precision and intervals | The conventions that make statistical text pass QC first time — decimals, denominators, intervals, and the CONSORT… | 3 quiz · 1 drill |
| 2.5 | Biomarkers, ROC curves and diagnostic accuracy | Sensitivity, specificity, predictive values, and AUC — the essential statistics of companion diagnostics, patient… | 3 quiz |
| Week 3 — Trial statistics | |||
| 3.1 | Randomisation, blinding and allocation | Four separate safeguards that writers routinely collapse into one word — and the interview question that separates… | 3 quiz · 1 drill |
| 3.2 | Analysis populations | ITT, mITT, per-protocol, evaluable, safety — five populations, five different denominators, and the mistake of using… | 3 quiz · 1 drill |
| 3.3 | Estimands, intercurrent events and missing data | ICH E9(R1) — the framework that forces you to state precisely what question a trial is answering, before anyone looks… | 3 quiz · 1 drill |
| 3.4 | Time-to-event and survival analysis | Kaplan–Meier curves, censoring, hazard ratios and the proportional hazards assumption — the analysis you will describe… | 3 quiz · 1 drill · 2 fig |
| Week 4 — Reading and reporting | |||
| 4.1 | Non-inferiority, confounding and IPW | Two designs where the usual logic inverts — non-inferiority trials, where a non-significant result is the goal, and… | 3 quiz · 1 drill · 1 fig |
| 4.2 | Subgroups, forest plots and interaction | The most over-interpreted figure in medicine — how to read one properly, why the interaction p value matters more than… | 3 quiz · 1 drill · 1 fig |
| 4.3 | Reading tables, figures and listings | The TFL pack is where your Results section comes from. Knowing how to navigate it, what to cross-check, and which… | 3 quiz · 1 drill |
| 4.4 | Capstone and exit assessment | A full output pack, a Results section to write, and twenty seeded statistical errors in a draft to catch — the task an… | 2 drill |
| 4.5 | HEOR preview: from clinical to economic evidence | The statistical skills you have built read clinical data — but payers, HTA bodies, and formulary committees read… | 3 quiz · 3 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — The document map | |||
| 1.1 | Source document diagnostic | Twenty-four questions on the documents you will be handed and expected to work from — and a personal study order for… | — |
| 1.2 | The document ecosystem | Twelve documents, who owns each one, what it can tell you, and — most importantly — what it cannot | 3 quiz · 1 drill · 1 fig |
| 1.3 | The protocol | A hundred and fifty pages with a fixed structure. Learn the structure and you can answer any design question in ninety… | 3 quiz · 1 drill |
| 1.4 | The investigator's brochure | The document that tells you what is already known about the product — and contains the one section with direct… | 3 quiz · 1 drill |
| Week 2 — The statistical spine | |||
| 2.1 | The statistical analysis plan | One document, usually forty pages, that governs what every later claim is allowed to say. If you read only one page of… | 3 quiz · 1 drill |
| 2.2 | Navigating the output pack | Nine hundred pages with a numbering system inherited from ICH E3. Learn the map and you can find anything in under a… | 3 quiz · 1 drill · 1 fig |
| 2.3 | Reading tables | Denominators, footers, and seven cross-checks that catch most of what quality control would otherwise send back | 3 quiz · 1 drill |
| 2.4 | Reading figures and listings | Survival curves, forest plots and patient-level data — what each one will tell you, and what it will let you claim if… | 3 quiz · 1 drill |
| Week 3 — Reports and records | |||
| 3.1 | The clinical study report | ICH E3 gives every CSR the same skeleton. Learn sixteen section numbers once and you can navigate any sponsor's report | 3 quiz · 1 drill · 1 fig |
| 3.2 | Safety documents | DSURs, PBRERs, narratives and line listings — a document family with its own vocabulary, its own timelines, and… | 3 quiz · 1 drill |
| 3.3 | CRFs and patient-level data | The fastest way to answer whether a variable exists at all — and the boundary you must not cross when handling… | 3 quiz · 1 drill |
| 3.4 | Labelling and regulatory documents | SmPC, USPI, CCDS and the eCTD — the documents that define what may be said about an approved product, and which one… | 3 quiz · 1 drill |
| Week 4 — Working from sources | |||
| 4.1 | Traceability and the number sheet | Every number in every deliverable must trace back to one output. The discipline that makes your work checkable — by… | 3 quiz · 1 drill · 1 fig |
| 4.2 | Writing the query | What to raise, who to ask, and how to write it so it gets answered in one round. The skill that most quickly changes… | 3 quiz · 1 drill |
| 4.3 | From source to deliverable | The same output pack feeds a manuscript, a congress abstract, a slide deck and a medical information response — and… | 3 quiz · 1 drill |
| 4.4 | Capstone and exit assessment | A full document set with eighteen planted problems. The task is not to write anything — it is to find what is wrong… | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Foundations & Primary Designs | |||
| 1.1 | Why Appraise? The Cost of Uncritical Reading | Understanding why medical writers must evaluate evidence — not just summarise it | 2 quiz · 3 drill |
| 1.2 | Study Design Hierarchy and When It Breaks | The evidence pyramid — its power, its limits, and when to trust a case series over an RCT | 3 quiz · 3 drill |
| 1.3 | Reading an RCT Through the CONSORT Lens | Using the CONSORT checklist as a critical reading tool to spot methodological red flags | 3 quiz · 3 drill |
| 1.4 | Reading Observational Studies: STROBE and Bias | Identifying confounding, immortal time bias, and other threats to validity in non-randomised research | 3 quiz · 3 drill |
| Week 2 — Risk of Bias & Evidence Certainty | |||
| 2.1 | Risk of Bias: RoB 2 for RCTs | Mastering the Cochrane Risk of Bias 2 tool — the standard for assessing randomised trial quality | 3 quiz · 3 drill |
| 2.2 | Non-Randomised Interventions: ROBINS-I | Assessing non-randomised studies and diagnostic accuracy studies with the right tools | 2 quiz · 3 drill |
| 2.3 | Diagnostic Accuracy & Biomarkers: QUADAS-2 | Evaluating diagnostic tests, screening tools, and precision biomarkers — and the unique spectrum and verification… | 1 quiz · 1 drill |
| 2.4 | GRADE: Rating the Certainty of Evidence | The single most important framework in evidence evaluation — and the one medical writers use across every domain | 4 quiz · 4 drill |
| Week 3 — Synthesis, NMAs & Systematic Reviews | |||
| 3.1 | Publication Bias and Selective Reporting | Detecting the evidence that is missing — and understanding why it matters more than the evidence that is present | 2 quiz · 3 drill |
| 3.2 | Reading Meta-analyses: Beyond the Forest Plot | Interpreting heterogeneity, prediction intervals, and subgroup credibility in pooled analyses | 3 quiz · 3 drill |
| 3.3 | Network Meta-Analysis (NMA) & Indirect Comparisons | Navigating network geometry, the transitivity assumption, consistency equations, and SUCRA rankings when direct… | 1 quiz · 1 drill |
| 3.4 | Appraising Systematic Reviews: AMSTAR 2 & ROBIS | Evaluating the methodological quality of systematic literature reviews — distinguishing high-quality evidence syntheses… | 1 quiz · 1 drill |
| Week 4 — RWE, Health Economics & Capstone | |||
| 4.1 | Real-World Evidence Appraisal | Target trial emulation, DAGs, and the gap between RWE claims and causal inference | 2 quiz · 3 drill |
| 4.2 | Health Economic Models & PROs: CHEERS & Drummond | Critically evaluating cost-effectiveness analyses, Markov decision models, QALYs, and patient-reported outcomes for HTA… | 1 quiz · 1 drill |
| 4.3 | Applying Appraisal Across Domains | How critical appraisal maps to publications, regulatory, PV, HEOR, medical affairs, devices, and medical information | 3 quiz · 3 drill |
| 4.4 | Capstone: Full Appraisal of a Published Study | Apply everything you have learned — design, bias, GRADE, and evidence synthesis — to a complete appraisal exercise | 5 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — The regulatory environment | |||
| 1.1 | The Regulatory Authorities: Who Governs What | Recognising the major regulatory agencies and knowing which one governs your product | 3 quiz · 2 drill |
| 1.2 | Drug Development Lifecycle: Where Documents Live | Mapping the development timeline so you know which document belongs to which phase | 3 quiz · 3 drill |
| 1.3 | The Common Technical Document (CTD/eCTD) | Learning the five-module structure that organises every major regulatory submission | 3 quiz · 2 drill |
| 1.4 | ICH Guidelines Beyond GCP | A reading-level map of the ICH guidelines a medical writer will need to look up | 3 quiz · 2 drill |
| Week 2 — Safety, devices, and pathways | |||
| 2.1 | Pharmacovigilance and Safety Landscape | The vocabulary of drug safety — what these documents are, not how to write them | 2 quiz · 2 drill |
| 2.2 | Medical Devices: A Different Regulatory World | Why device regulation uses a different vocabulary and evidence model than drugs | 2 quiz · 2 drill |
| 2.3 | Regional Variations: US, EU, Japan, India | Understanding why the same product looks different in different regulatory dossiers | 3 quiz · 2 drill |
| 2.4 | Regulatory Agency Meetings & Briefing Packages | Authoring Type A, B, and C meeting briefing documents for the FDA and Scientific Advice packages for the EMA | 1 quiz · 1 drill |
| Week 3 — Specialized pathways & document strategy | |||
| 3.1 | Pediatric Regulations & Global Pediatric Plans (PIP / PSP) | Navigating the EU Pediatric Regulation and US PREA / BPCA — drafting Paediatric Investigation Plans, waivers, and… | 1 quiz · 1 drill |
| 3.2 | 505(b)(2) Hybrid Applications & Biosimilar Submissions | Understanding abbreviated and bridging regulatory dossiers — establishing bioequivalence, scientific bridging, and… | 1 quiz · 1 drill |
| 3.3 | Orphan Drugs & Rare Disease Regulatory Strategy | Authoring Orphan Drug Designation applications — medical plausibility, prevalence calculations, and establishing… | 1 quiz · 1 drill |
| 3.4 | The Regulatory Document Universe | Building a mental map of every document type you will encounter — who reads it, when, and how long it takes | 3 quiz · 3 drill |
| Week 4 — Lifecycle, quality & career mastery | |||
| 4.1 | Document Lifecycle and Quality Management | Why formatting, versioning, and QC are regulatory risk issues — not bureaucracy | 3 quiz · 3 drill |
| 4.2 | Strategic Regulatory Intelligence & Lifecycle Management | Tracking competitor precedents, FDA Advisory Committee outcomes, label expansions, and Type II variations | 1 quiz · 1 drill |
| 4.3 | Mapping Professional Domains & Industry Transition Blueprint | Navigating medical writing roles across Pharma, Biotech, CROs, MedComms, and Health Authorities | 1 drill |
| 4.4 | Capstone: Mapping Your Pathway | Connecting the regulatory landscape to the seven professional domains of medical writing | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Before you write | |||
| 1.1 | Manuscript diagnostic | Twenty-four questions across authorship, structure, claim discipline and submission — and a personal study order for… | — |
| 1.2 | Authorship and the publication plan | Who goes on the paper, who does not, and the decisions that must be settled before a word is written — because settling… | 3 quiz · 1 drill |
| 1.3 | From source documents to a data narrative | The protocol, the SAP and the output pack contain everything the manuscript needs and far more than it can hold.… | 3 quiz · 1 drill |
| 1.4 | The core message and the storyboard | One sentence, agreed before drafting, that determines the title, the lead result, the figures and the argument.… | 3 quiz · 1 drill |
| Week 2 — Results | |||
| 2.1 | Results architecture | What goes in what order, and the single discipline that defines the section: Results report, they do not interpret | 3 quiz · 1 drill · 1 fig |
| 2.2 | Tables, figures and text | Three ways to present a finding and one right answer for each — plus the flow diagram every trial and cohort study is… | 3 quiz · 1 drill · 1 fig |
| 2.3 | Writing the numbers | Baseline, efficacy and safety — what to state, what to omit, and the reporting conventions that decide whether a draft… | 3 quiz · 1 drill |
| 2.4 | The Results clinic | A full output pack and a blank page. Everything from Week 2 applied at once, then scored against a rubric | 1 drill |
| Week 3 — Discussion | |||
| 3.1 | Discussion architecture | Five moves in a fixed order. Reviewers read for them, and a Discussion that omits one is the most common reason a sound… | 3 quiz · 1 drill · 1 fig |
| 3.2 | Interpretation without overclaim | The design determines which verbs are available to you. Choosing one your data cannot support is the most consequential… | 3 quiz · 1 drill |
| 3.3 | Limitations that strengthen | A limitations paragraph is not an apology and not a disclaimer. Done properly it pre-empts the reviewer, and it is one… | 3 quiz · 1 drill |
| 3.4 | The Discussion clinic | A full Discussion against a word budget, scored on structure, calibration and limitations at once | 1 drill |
| Week 4 — Framing and submission | |||
| 4.1 | The Introduction, written last | Three moves, four hundred words, and one job: make the reader believe the study needed to exist. It is taught last… | 3 quiz · 1 drill |
| 4.2 | Methods, abstract and title | Reproducibility, compression and findability — three different jobs, and the abstract is the only part of your paper… | 3 quiz · 1 drill |
| 4.3 | Submission and peer review | The cover letter, the submission package, and the response to reviewers — a document whose craft determines whether a… | 3 quiz · 1 drill · 1 fig |
| 4.4 | Capstone and exit assessment | A finished draft with twenty seeded faults across every section — the review task a senior writer is actually paid to… | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — The function and the rules | |||
| 1.1 | Medical information diagnostic | Twenty-four questions on the function, the compliance boundary and the documents — and a personal study order for the… | — |
| 1.2 | Reactive, not proactive | One distinction governs almost everything in this function. The same sentence is permissible in answer to a question… | 3 quiz · 1 drill · 1 fig |
| 1.3 | Intake and triage | What you capture at the start determines what you may say, who else must be told, and whether the interaction survives… | 3 quiz · 1 drill · 1 fig |
| 1.4 | Sources and the evidence hierarchy | Which source answers which question, in what order, and how unpublished data may legitimately be used | 3 quiz · 1 drill · 1 fig |
| Week 2 — The response document | |||
| 2.1 | The standard response document | The core deliverable of the function — pre-approved, balanced, referenced, and written so that every enquirer gets the… | 3 quiz · 1 drill · 1 fig |
| 2.2 | Writing the response | Balanced, factual, non-promotional — three words that are easy to agree with and hard to execute under pressure to be… | 3 quiz · 1 drill |
| 2.3 | Referencing and data on file | Every statement traceable to a source the enquirer could in principle obtain — and the controlled route for data that… | 3 quiz · 1 drill |
| 2.4 | The SRD clinic | A full standard response document from an enquiry and a source set, scored against a sixteen-point rubric | 1 drill |
| Week 3 — Harder cases | |||
| 3.1 | Off-label enquiries | Permitted, conditional, and tightly bounded. The area where the function carries most risk and where the rules are most… | 3 quiz · 1 drill |
| 3.2 | Adverse events and complaints | The obligation that is triggered by information reaching you, not by anyone asking you to act on it — and the commonest… | 3 quiz · 1 drill |
| 3.3 | Comparative and pipeline questions | Two question types where the honest answer is usually that the evidence does not exist — and where manufacturing one is… | 3 quiz · 1 drill |
| 3.4 | Audience tailoring | The same question from a consultant and from a patient produces two different documents — and only one of them may… | 3 quiz · 1 drill |
| Week 4 — Running the function | |||
| 4.1 | Global and local | A globally approved document is not usable anywhere until someone has checked it against the local label — and… | 3 quiz · 1 drill |
| 4.2 | Governance and metrics | Version control, archiving, review cycles and the numbers the function reports — what makes the whole operation… | 3 quiz · 1 drill |
| 4.3 | Channels and escalation | Call, email, congress stand, social media — the rules do not change with the channel, but the pressure to break them… | 3 quiz · 1 drill |
| 4.4 | Capstone and exit assessment | One enquiry containing eighteen distinct obligations and traps. The task is to handle it correctly end to end | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Planning and abstracts | |||
| 1.1 | Congress materials diagnostic | Twenty-four questions across abstracts, posters, presentations and the compliance rules that govern all three | — |
| 1.2 | The congress ecosystem | Deadlines months ahead of the data, embargoes with teeth, and encore rules that decide whether the same work can be… | 3 quiz · 1 drill · 1 fig |
| 1.3 | The abstract | Two thousand characters, four sections, and a permanent citable record. Compression without loss is the entire skill | 3 quiz · 1 drill |
| 1.4 | The abstract clinic | A degraded abstract with fourteen planted faults, against a hard character limit and a title requirement | 1 drill |
| Week 2 — Posters | |||
| 2.1 | Poster architecture | You have three seconds to earn a reader and ninety seconds to keep one. Layout decides both, before a word is read | 3 quiz · 1 drill · 1 fig |
| 2.2 | Data display | A manuscript figure dropped onto a poster is unreadable. Redrawing for distance is the difference between a figure that… | 3 quiz · 1 drill |
| 2.3 | Poster copy and the QR ecosystem | How much text a board can carry, what belongs behind a code, and why linked material is still congress material | 3 quiz · 1 drill |
| 2.4 | The poster clinic | A poster brief with sixteen planted problems, spanning layout, data display, copy and compliance | 1 drill |
| Week 3 — Oral presentations | |||
| 3.1 | Slide architecture | Ten minutes, twelve slides, and an audience that cannot re-read anything. The narrative arc has to carry them | 3 quiz · 1 drill · 1 fig |
| 3.2 | Data slides | One message per slide, stated in the title. Everything else on the slide exists to support that one message | 3 quiz · 1 drill |
| 3.3 | Delivery and questions | Timing, the room, and the two minutes of questions where a good presentation is confirmed or undone | 3 quiz · 1 drill |
| 3.4 | The presentation clinic | A deck plan with fourteen planted problems across structure, slide design and what may be said aloud | 1 drill |
| Week 4 — Compliance and workflow | |||
| 4.1 | Embargo, encore and disclosure | Three rules with real consequences: withdrawal from the programme, rejection at submission, and a compliance finding | 3 quiz · 1 drill |
| 4.2 | Authorship and review | The same contribution criteria as a manuscript, on a calendar that runs backwards from a deadline that cannot move | 3 quiz · 1 drill |
| 4.3 | After the congress | Reuse, plain-language summaries and the relationship between the abstract and the manuscript that follows it | 3 quiz · 1 drill |
| 4.4 | Capstone and exit assessment | A full congress project with eighteen planted problems across timeline, materials and compliance | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — The Boundary & Governance | |||
| 1.1 | Field medical diagnostic | Twenty-four questions on the boundary, the materials, the review process and the intelligence the function produces | — |
| 1.2 | Scientific exchange and its boundary | The line is not drawn by job title, setting or sincerity. It is drawn by purpose and content | 3 quiz · 1 drill · 1 fig |
| 1.3 | The field medical toolkit | What materials the function uses, who owns each one, and which ones must never cross the boundary in either direction | 3 quiz · 1 drill |
| 1.4 | Surviving MLR review | Three reviewers assessing three different things. Understanding what each is looking for turns four review rounds into… | 3 quiz · 1 drill · 1 fig |
| Week 2 — Field Deliverables & Digital Content | |||
| 2.1 | Deck architecture for field use | A deck that supports dialogue rather than delivering a message — modular, navigable, and built to be entered at any… | 3 quiz · 1 drill |
| 2.2 | Referencing every claim | Every statement traceable to something the audience could obtain — and the checks that stop a deck citing superseded… | 3 quiz · 1 drill |
| 2.3 | Digital Field Tools, iDVAs & Modular Content | Designing interactive digital visual aids (iDVAs), Veeva CRM/CLM multichannel modules, and compliant non-linear… | 3 quiz · 1 drill |
| 2.4 | Data on file and unapproved content | Where the boundary is sharpest: unpublished data, off-label uses and pipeline compounds in a proactive material | 3 quiz · 1 drill |
| Week 3 — Stakeholder Strategy & Scientific Deliverables | |||
| 3.1 | Key Opinion Leader (KOL) Mapping & Scientific Engagement Plans | Establishing objective thought-leader tiering criteria, institutional influence mapping, and compliant annual… | 3 quiz · 1 drill |
| 3.2 | Engagement guides and FAQs | Resources that support consistent dialogue without becoming scripts — and the reactive content that must never be… | 3 quiz · 1 drill |
| 3.3 | Advisory boards | A genuine need for advice, a defined question, and experts selected for expertise. Everything else is a promotional… | 3 quiz · 1 drill |
| 3.4 | Disease State Education & Internal Medical Training | Authoring unbranded disease awareness slide decks, pathophysiology backgrounders, and compliant internal medical… | 3 quiz · 1 drill |
| Week 4 — Medical Intelligence, Research & Capstone | |||
| 4.1 | Insight capture | The function's most valuable output and its least taught. An insight is not what a clinician said — it is what it… | 3 quiz · 1 drill |
| 4.2 | Investigator-Initiated Studies (IIS/IST) & Research Grants | Managing unsolicited investigator research proposals, Medical Review Committee (MRC) charters, and drug supply… | 3 quiz · 1 drill |
| 4.3 | The deck clinic | A field deck with sixteen planted problems across architecture, referencing, balance and permissibility | 1 drill |
| 4.4 | Capstone and exit assessment | A full field medical scenario with sixteen problems across materials, activities and the boundary | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Week 1 — Modern GCP Architecture & Quality by Design | |||
| 1.1 | GCP diagnostic | Twenty-four questions on the revised guideline, the roles it defines, and what each principle means for the documents… | — |
| 1.2 | What E6(R3) changed | A restructure with a different philosophy — and a set of consequences for the documents you write | 3 quiz · 1 drill · 1 fig |
| 1.3 | The principles in practice | A small set of principles, applied consistently — and what each one asks of a document you are writing | 6 quiz · 2 drill · 1 fig |
| 1.4 | Decentralized Clinical Trials & Digital Health Technologies | Operationalizing ICH E6(R3) Annex 2: eConsent, Direct-to-Patient logistics, wearables, and remote data oversight | 1 drill |
| Week 2 — Clinical Governance, Oversight & Patient Safeguards | |||
| 2.1 | Roles and responsibilities | Sponsor, investigator, ethics committee — who owns what, and why delegation never transfers responsibility | 3 quiz · 1 drill |
| 2.2 | Informed consent | A process, not a form — and the document a medical writer most often has direct power to improve | 3 quiz · 1 drill · 1 fig |
| 2.3 | Independent Oversight Bodies: DMC & CEC Charters | Establishing Data Monitoring Committees (DSMB) and Clinical Endpoint Adjudication Committees under ICH E6 & FDA/EMA… | 1 drill |
| 2.4 | Investigational Product Management & Cold Chain Integrity | Handling accountability, blinding integrity, temperature excursions, and Direct-to-Patient drug logistics | 1 drill |
| Week 3 — Data Integrity, Safety & Regulatory Reporting | |||
| 3.1 | Safety reporting | Who reports what, to whom, and how fast — plus the three-term vocabulary that gets confused constantly | 3 quiz · 1 drill |
| 3.2 | Data governance and records | Data integrity across the lifecycle, and a trial master file that lets someone reconstruct what happened | 3 quiz · 1 drill |
| 3.3 | Deviations, non-compliance and breaches | Three escalating categories, one judgement to get right — and the documents that record each | 3 quiz · 1 drill |
| 3.4 | Essential Documents & Trial Master File Mastery | Structuring the eTMF, navigating the DIA Reference Model, and ensuring inspection readiness | 1 drill |
| Week 4 — Global Operations, Inspections & Capstone Mastery | |||
| 4.1 | Multi-Regional Clinical Trials & Cross-Jurisdictional Ethics | Executing global trials under ICH E17: ethnic sensitivity (ICH E5), regional standards of care, and multi-country GCP… | 1 drill |
| 4.2 | Site Audits & Health Authority Inspections | Navigating FDA BIMO inspections, Form 483s, Warning Letters, EMA GCP inspections, and CAPA remediation | 1 drill |
| 4.3 | The GCP-Medical Writer Interface | Authoring audit-ready protocols, CSR Section 9.1 GCP compliance statements, protocol deviation summaries, and patient… | 1 drill |
| 4.4 | Capstone and exit assessment | A trial with sixteen GCP problems across design, conduct, records and safety | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 · Value Foundations & Modeling | |||
| 1.1 | The HEOR Landscape & Healthcare Decision-Makers | Navigating payer archetypes, US P&T committees vs EU HTA bodies, and the critical tension between statistical… | 3 quiz · 1 drill · 1 fig |
| 1.2 | Economic Models, QALYs & ICER | Deconstructing Cost-Utility Analysis, Markov state-transition mechanics, Quality-Adjusted Life Year calculus, and… | 3 quiz · 1 drill · 1 fig |
| 1.3 | Budget Impact Models (BIM): Sizing, Horizons & Budget Offsets | How US and commercial payers evaluate the aggregate financial consequences of adopting a new medicine over 1 to 5 years. | 1 quiz · 1 drill |
| 1.4 | Patient-Reported Outcomes (PROs), QoL & psychometrics | Integrating HRQoL instruments (EQ-5D-5L, EORTC QLQ-C30), COSMIN psychometric validation, and Minimal Clinically… | 1 drill |
| Part 2 · Global Market Access Deliverables | |||
| 2.1 | The Global Value Dossier (GVD): Core Architecture & Synthesis | The 6-section master source document for global market access: value storytelling, clinical-economic synthesis, and… | 1 quiz · 1 drill |
| 2.2 | The AMCP Formulary Dossier (Format 4.1) & PIE Act Communications | Authoring unapproved and approved product dossiers for US managed care Pharmacy & Therapeutics (P&T) committees. | 1 quiz · 1 drill |
| 2.3 | HTA Submissions: UK NICE, Canada CADTH & Australia PBAC | Statutory single-payer submissions, indirect treatment comparisons, and defending survival extrapolation models. | 1 quiz |
| 2.4 | The new EU-HTA regulation & Joint Clinical Assessments (JCA) | Navigating EU Regulation 2021/2282, the central JCA dossier, multi-PICO consolidations, and Member State national… | 1 drill |
| Part 3 · Evidence Generation & Pricing | |||
| 3.1 | Network Meta-Analysis (NMA) & Indirect Comparisons | Synthesizing multi-arm trials, transitivity checks, league tables, and interpreting SUCRA rankings for HTA bodies. | 1 quiz |
| 3.2 | Real-World Evidence (RWE) & Patient-Reported Outcomes (PROs) | Deriving health utilities from validated instruments (EQ-5D-5L, SF-36) and leveraging real-world registries for payer… | 1 quiz |
| 3.3 | Early Access Programs (EAP) & compassionate use | Navigating pre-approval access pathways (US Expanded Access, France Accès Précoce, UK EAMS) and capturing… | 1 drill |
| 3.4 | Value-Based Healthcare (VBHC) & Managed Entry Agreements | Designing financial and outcomes-based Managed Entry Agreements (MEA), annuity payments for gene therapies, and payer… | 1 drill |
| Part 4 · Payer Objections & Capstone | |||
| 4.1 | Payer Objections & Rebuttal Writing: Overcoming HTA Hurdles | Authoring responses to HTA consultation documents, addressing immature survival extrapolations and generalizability… | 1 quiz · 1 drill |
| 4.2 | Value Briefing & Claim Clinic: Translating Surrogate Endpoints | Translating surrogate trial endpoints (PFS, ORR, biomarker drops) into defensible, audit-ready payer value claims… | 1 quiz |
| 4.3 | Value-Based Pricing (VBP) & global access strategy | Harmonizing international pricing archetypes (US WAC/Rebates, German AMNOG, French ASMR, UK CAA) and value story… | 1 drill |
| 4.4 | Capstone Project: GVD Executive Defense & Comprehensive HTA Value Story | Comprehensive capstone evaluating an oncology GVD executive summary against P&T and NICE evidentiary standards. | 1 quiz · 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 · Foundations, Classification & SOTA | |||
| 1.1 | EU MDR 2017/745 vs. US FDA 510(k)/PMA | Navigating regulatory philosophy, classification frameworks, General Safety and Performance Requirements (GSPR), and… | 1 drill |
| 1.2 | The Clinical Evaluation Framework: MEDDEV 2.7/1 Rev 4 & MDCG | Understanding the 5 continuous stages of clinical evaluation, methodological quality appraisal, and regulatory guidance… | 1 drill |
| 1.3 | State of the Art (SOTA) Literature Protocols & Benchmarking | Constructing reproducible literature search strings, PRISMA flow diagrams, clinical practice guideline extraction, and… | 1 drill |
| 1.4 | In Vitro Diagnostic Regulation (EU IVDR) & PER | Navigating EU IVDR 2017/746 classification (Classes A–D), Companion Diagnostics (CDx), and the Performance… | 1 drill |
| Part 2 · CEP, Equivalence & CER Authoring | |||
| 2.1 | The Clinical Evaluation Plan (CEP) & GSPR Mapping | Architecting the pre-market blueprint, establishing measurable clinical endpoints, and mapping General Safety and… | 1 drill |
| 2.2 | Equivalence Demonstrations under EU MDR (MDCG 2020-5) | Navigating the rigorous 3-pillar equivalence criteria (Technical, Biological, Clinical), technical file access… | 1 drill |
| 2.3 | Clinical Evaluation Report (CER) Architecture & Synthesis | Structuring compliant CER sections, evidence appraisal rubrics, safety/performance data integration, and drafting… | 1 drill |
| 2.4 | Summary of Safety & Clinical Performance (SSCP) | Authoring public transparency documents for EUDAMED under MDR Article 32 & MDCG 2019-9, managing layperson… | 1 drill |
| Part 3 · PMS, PMCF & Digital Health | |||
| 3.1 | Post-Market Clinical Follow-up (PMCF) Plans & Reports | Authoring MDCG 2020-7 templates, designing prospective registries, user survey methodologies, and PMCF Evaluation… | 1 drill |
| 3.2 | Periodic Safety Update Reports (PSUR) for Medical Devices | Drafting Article 86 PSURs, sales volume denominators, incident rate calculations, and MDCG 2022-21 Notified Body review… | 1 drill |
| 3.3 | Benefit-Risk Determination & Risk Management (ISO 14971) | Harmonizing the CER with the Risk Management File (ISO 14971:2019), quantitative benefit-risk assessment, and residual… | 1 drill |
| 3.4 | Software as a Medical Device (SaMD) & AI/ML | Evaluating digital health algorithms, MDR Rule 11 classification, MDCG 2019-11 and AI clinical performance validation. | 1 drill |
| Part 4 · Notified Body Audits & Capstone | |||
| 4.1 | Notified Body Clinical Audits & Deficiency Patterns | Analyzing common Notified Body findings, clinical audit checklists, major vs minor non-conformities, and defensive… | 1 drill |
| 4.2 | Responding to Deficiencies (RtD) & CER Remediation | Formulating structured Response to Deficiencies (RtD) packages, resolving major non-conformities, and managing Notified… | 1 drill |
| 4.3 | CE Mark Technical Documentation Lifecycle & EUDAMED | Managing Annex II/III technical files, EUDAMED database modules, vigilance reporting, and managing significant device… | 1 drill |
| 4.4 | Master Capstone: End-to-End CER Defense & Deficiency Resolution | Simulated Notified Body clinical technical file audit, resolving complex multi-deficiency findings, and authoring the… | 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 · Core Clinical Trial Documents | |||
| 1.1 | The regulatory writing landscape | What regulatory medical writing is, where it fits in drug development, and the documents a medical writer authors | 3 quiz · 1 drill |
| 1.2 | Clinical study protocols & amendments (ICH M11) | Designing regulatory-grade study protocols, Schedule of Assessments (SoA), endpoint operationalization, estimands (ICH… | 1 drill |
| 1.3 | The Investigator's Brochure | IB structure per ICH E6(R2), writing for investigators, and managing annual updates | 3 quiz · 1 drill |
| 1.4 | The Clinical Study Report | ICH E3 structure, the synopsis, efficacy and safety sections, and the errors that trigger regulatory queries | 3 quiz · 1 drill |
| Part 2 · Safety Writing & Special Programs | |||
| 2.1 | Patient narratives | Writing factual narratives for SAEs, deaths, and discontinuations — without advocacy language | 3 quiz · 1 drill |
| 2.2 | Pediatric plans (PIP / PSP) & orphan designations | Navigating pediatric development regulations (EU PIP vs US iPSP), waivers, deferrals, and Orphan Drug Designation (ODD)… | 1 drill |
| 2.3 | Prescribing information and labelling | USPI vs SmPC, PLR format, QRD template, adverse reaction tables, and label negotiations | 3 quiz · 1 drill |
| 2.4 | Regulatory agency interactions & briefing documents | Authoring FDA Briefing Books (Type A/B/C) and EMA Scientific Advice packages that secure agency alignment on clinical… | 1 drill |
| Part 3 · CTD Dossier & Module 2 Summaries | |||
| 3.1 | Technology and the future | eCTD specifications, structured content authoring, AI tools, and the skills that technology will not replace | 3 quiz · 1 drill |
| 3.2 | Module 2.7: Clinical summaries (2.7.1 – 2.7.6) | Authoring the Summary of Clinical Efficacy (SCE), Summary of Clinical Safety (SCS), integrated pools, and study synopses | 1 drill |
| 3.3 | Module 2 documents and benefit-risk | Clinical Overview, Clinical Summary, integrated summaries, and the benefit-risk assessment | 3 quiz · 1 drill |
| 3.4 | Accelerated pathways, expedited approvals & RWE | FDA Fast Track, Breakthrough, Accelerated Approval, EMA PRIME, Conditional Authorisation and Real-World Evidence (RWE) | 1 drill |
| Part 4 · Global Submissions & Lifecycle | |||
| 4.1 | Global regulatory writing | FDA vs EMA vs PMDA vs NMPA requirements, multi-regional submissions, and regional adaptations | 3 quiz · 1 drill |
| 4.2 | Regulatory submissions and responses | Complete Response Letters, Information Requests, EMA List of Questions, and writing effective responses | 3 quiz · 1 drill |
| 4.3 | Regulatory quality, transparency & anonymization | Mastering 100% data verification, cross-document QC, EMA Policy 0070, EU CTIS transparency and anonymization… | 1 drill |
| 4.4 | Capstone: career and competencies | In-house vs CRO vs freelance, core competencies, and an integrated capstone exercise | 3 quiz · 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 · Core PV Concepts & ICSR | |||
| 1.1 | Introduction to pharmacovigilance | What pharmacovigilance is, the ICH E2 guideline family, and the medical writer's role in the safety system | 3 quiz · 1 drill |
| 1.2 | The Individual Case Safety Report | ICSR structure per E2B(R3), narrative writing, MedDRA coding, and expedited reporting timelines | 3 quiz · 1 drill |
| 1.3 | Causality assessment & safety case narratives | Mastering WHO-UMC causality algorithms, Naranjo scoring, Bradford Hill criteria and structured ICSR narrative writing | 1 drill |
| 1.4 | Reference Safety Information (RSI) & SUSAR reporting | Managing Reference Safety Information (RSI) in the Investigator's Brochure, expectedness determination and expedited… | 1 drill |
| Part 2 · Aggregate Reports & Signals | |||
| 2.1 | The DSUR | Development Safety Update Report per ICH E2F — annual safety reviews during clinical development | 3 quiz · 1 drill |
| 2.2 | Signal management & disproportionality analysis | Mastering the signal management lifecycle (GVP Module IX), PRR, ROR, Bayesian disproportionality algorithms and SMQ… | 1 drill |
| 2.3 | The PBRER | Periodic Benefit-Risk Evaluation Report per ICH E2C(R2) — structure, data integration, and benefit-risk analysis | 3 quiz · 1 drill |
| 2.4 | Safety labelling harmonization & CCDS maintenance | Maintaining the Company Core Safety Information (CCSI), SmPC Section 4.8 frequency tables, USPI Warnings and labelling… | 1 drill |
| Part 3 · Risk Management & Post-Marketing | |||
| 3.1 | Risk management | PSMF, Risk Management Plans, REMS, and the regulatory framework for risk minimisation | 3 quiz · 1 drill |
| 3.2 | Risk minimisation measures & educational tools | Designing routine and additional risk minimisation measures (aRMM), HCP guides, patient alert cards and measuring… | 1 drill |
| 3.3 | Real-world evidence and the future | RWE in pharmacovigilance, the FDA Sentinel System, evolving regulations, and the next generation of safety surveillance | 3 quiz · 1 drill |
| 3.4 | Urgent safety restrictions & DHPC letters | Managing regulatory emergency procedures (USR), authoring Direct Healthcare Professional Communications (DHPC) and PRAC… | 1 drill |
| Part 4 · Audits, Compliance & Capstone | |||
| 4.1 | MedDRA and global reporting | MedDRA hierarchy and version management, RSI/CCDS, and managing periodic reports across jurisdictions | 3 quiz · 1 drill |
| 4.2 | Inspections and compliance | PV inspections, common findings, audit trails, and Corrective and Preventive Action (CAPA) plans | 3 quiz · 1 drill |
| 4.3 | AI, automation & NLP in safety writing | Deploying automated ICSR intake, NLP narrative generation, machine learning signal triage and 21 CFR Part 11 validation… | 1 drill |
| 4.4 | Capstone: the safety communication cycle | An integrated capstone walking through a complete pharmacovigilance response from ICSR to regulatory action | 3 quiz · 1 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 · Scoping, Protocol & Search Strategy | |||
| 1.1 | What a systematic review is (and is not) | The difference between systematic and narrative reviews, and why the method matters more than the conclusion | 3 quiz · 1 drill |
| 1.2 | Formulating the question | PICO, eligibility criteria, the protocol and PRISMA-P — because the question determines everything that follows | 3 quiz · 1 drill |
| 1.3 | The search strategy | Database selection, search syntax, Boolean logic, sensitivity and the documentation that makes a search reproducible | 3 quiz · 1 drill |
| 1.4 | Screening and selection | Title/abstract screening, full-text review, the PRISMA flow diagram and inter-rater reliability | 3 quiz · 1 drill · 1 fig |
| Part 2 · Critical Appraisal, Quality & Data Extraction | |||
| 2.1 | Risk of bias assessment | RoB 2 for randomised trials, ROBINS-I for observational studies, and the domain writers get wrong most often | 3 quiz · 1 drill |
| 2.2 | Critical appraisal for diagnostic & observational studies | Evaluating diagnostic accuracy (QUADAS-2) and non-randomised observational cohorts (Newcastle-Ottawa Scale) with… | 1 drill |
| 2.3 | Data extraction | Extraction forms, handling missing data, contacting authors, and why double extraction is not redundancy | 3 quiz · 1 drill |
| 2.4 | AI & software automation in evidence synthesis | Leveraging Covidence, Rayyan, DistillerSR, machine learning priority screening and LLMs under rigorous PRISMA 2020… | 1 drill |
| Part 3 · Quantitative Synthesis & Meta-Analysis Methods | |||
| 3.1 | Meta-analysis fundamentals | Effect measures, fixed-effect and random-effects models, forest plots, heterogeneity and prediction intervals | 3 quiz · 1 drill |
| Part ? | |||
| ?.32 | Subgroup analysis and publication bias | Pre-specified vs post-hoc subgroups, interaction tests, sensitivity analysis, funnel plots and Egger's test | 3 quiz · 1 drill |
| Part 3 · Quantitative Synthesis & Meta-Analysis Methods | |||
| 3.3 | Small-study effects, funnel plots & publication bias | Detecting reporting bias, mastering funnel plot interpretation, Egger's regression, Begg's test and trim-and-fill… | 1 drill |
| 3.4 | Advanced evidence synthesis: Network meta-analysis & SUCRA | Mastering indirect treatment comparisons (ITC), Bucher method, network geometry, transitivity, consistency and SUCRA… | 1 drill |
| Part 4 · Reporting, Evidence Certainty & Master Capstone | |||
| 4.1 | GRADE and certainty of evidence | The GRADE framework, rating certainty, Summary of Findings tables and the language that matches each level | 3 quiz · 1 drill |
| 4.2 | PRISMA 2020 | The 27-item checklist, the abstract checklist, the flow diagram and the items writers get wrong | 3 quiz · 1 drill |
| 4.3 | Living systematic reviews & rapid reviews for HTA | Dynamic continuous evidence surveillance (LSR), accelerated synthesis methodologies, and HTA Global Value Dossier… | 1 drill |
| 4.4 | Capstone: from protocol to publication | An integrated exercise taking you through every stage of a systematic review, from PICO question to final conclusion | 3 drill |
| # | Module | What it covers | Content |
|---|---|---|---|
| Part 1 — Foundations of medical communications | |||
| 1.1 | The medical communications landscape | What med comms is, its audiences and channels, and the boundary between medical and promotional communication | 3 quiz · 1 drill |
| 1.2 | Publication planning | Strategic publication plans, GPP guidelines, data inventory, publication sequence and authorship ethics | 3 quiz · 1 drill |
| 1.3 | Writing the primary publication | IMRAD for clinical trials, CONSORT compliance, results presentation, and balanced reporting of safety data | 3 quiz · 1 drill |
| 1.4 | Congress communications | Abstract writing, poster design, oral presentation development, speaker training and Q&A preparation | 3 quiz · 1 drill |
| Part 2 — Strategy and stakeholders | |||
| 2.1 | The scientific platform | Building the evidence-based messaging framework that guides all medical communications activities | 3 quiz · 1 drill |
| 2.2 | Advisory boards and medical education | Planning legitimate advisory boards, CME development, faculty management and compliance requirements | 3 quiz · 1 drill |
| 2.3 | Payer communications and health economics | Value dossiers, QALYs, ICERs, budget impact models, indirect treatment comparisons and HTA submissions | 3 quiz · 1 drill |
| 2.4 | Risk communications and crisis management | Safety signals, DHCP letters, label updates, media responses and crisis communication principles | 3 quiz · 1 drill |
| Part 3 — Channels and integration | |||
| 3.1 | Digital medical communications | Medical information websites, social media strategy, digital engagement, regulatory compliance in digital channels | 3 quiz · 1 drill |
| 3.2 | The integrated communications plan | Audience mapping, channel strategy, timeline development, resource planning and impact measurement | 3 quiz · 1 drill |
| 3.3 | Patient communications | Health literacy, plain language principles, patient education materials, visual design and audience testing | 3 quiz · 1 drill |
| 3.4 | Capstone: lifecycle strategy | An integrated capstone developing a full medical communications strategy from pre-approval through post-launch | 3 quiz · 1 drill |
| Part 4 — Publication standards & ethics | |||
| 4.1 | Reporting guidelines and registration | Every study type has a reporting guideline. Every interventional trial must be registered. These are not suggestions —… | 3 quiz · 2 drill |
| 4.2 | Research integrity and citation accuracy | Plagiarism detection, image manipulation, citation errors, and authorship disputes — the integrity issues that end… | 2 quiz · 3 drill |
| 4.3 | Journal selection and corrections | Choosing the right journal, spotting predatory publishers, and knowing how corrections and retractions work — the… | 2 quiz · 2 drill |
| 4.4 | Publication standards capstone | A full pre-submission quality check: reporting guideline compliance, registration verification, reference accuracy, and… | 1 drill |