MAB Registration Exam study plan

Map the end-to-end role of Medical Affairs across the product lifecycle, listing at least six distinct functions (scientific exchange, evidence generation, medical information, field medical, publications, internal medical review) and where each sits relative to R&D, Commercial, and Regulatory

Distinguish the core compliance frameworks that govern Medical Affairs activity (promotional vs non-promotional review, fair balance, off-label communication limits, Sunshine/transparency reporting) and write a one-line definition of each in your own words

Build a personal glossary of 40 Medical Affairs and regulatory terms with a definition and one example use for each

Draft a one-page comparison of how Medical Affairs operates in the US versus EU regulatory environments, noting at least three concrete differences

Sequence the drug development phases from target identification through Phase IV, stating the primary objective, typical subject numbers, and typical duration for each phase

Explain the purpose and content of an Investigational New Drug application and a marketing application, and identify which study types feed each

Differentiate Phase I designs (single ascending dose, multiple ascending dose, food effect) and state what each is designed to answer

Interpret the core clinical trial endpoints and statistics vocabulary (primary vs secondary endpoint, power, alpha, intention-to-treat vs per-protocol, confidence interval) and work through three practice calculations by hand

Trace the regulatory submission and review pathways for a new drug and for a supplemental indication, listing the sequence of meetings and submissions

Summarize the requirements for informed consent, institutional review board or ethics committee oversight, and protocol amendments, and identify three common compliance failures

Explain how Good Clinical Practice principles translate into site-level documentation expectations (source documents, delegation logs, monitoring visits)

Compare expedited and standard review designations and state the evidence threshold for each

Draft a mock regulatory question-and-answer set covering ten likely compliance scenarios and answer each with the governing principle

Define the scope and boundaries of Medical Information services, including response timelines, standard response letter structure, and documentation requirements

Draft three unsolicited medical information response letters (one on an approved indication, one on an off-label question, one on a safety question) using a fair-balanced, referenced structure

Describe the Medical Science Liaison role and differentiate it from sales, listing at least five activities that are appropriate and five that are not

Outline how field medical insights are captured, triaged, and routed internally, and identify who owns each step

Practice a 10-minute mock scientific exchange and self-score against a clarity, balance, and accuracy checklist

Distinguish the study designs used for evidence generation (randomized controlled trial, observational cohort, case-control, real-world evidence, pragmatic trial) and state one strength and one limitation of each

Explain the purpose and structure of a study protocol, including objectives, endpoints, inclusion/exclusion criteria, and statistical considerations

Compare endpoints used in registration trials versus those used in health economic and outcomes studies

Identify at least four sources of real-world data and evaluate the fitness-for-purpose of each for a stated research question

Design a one-page concept sheet for an evidence gap you identify in a therapy area of your choice

Define the core pharmacovigilance vocabulary (adverse event, serious adverse event, suspected unexpected serious adverse reaction, individual case safety report, signal) and state the reporting timeline associated with each

Outline the aggregate reporting obligations for periodic safety reports and describe what a signal detection and evaluation workflow looks like

Explain the components of a risk management plan, including identified risks, potential risks, and risk minimization measures

Work through five case vignettes and classify each event for seriousness and expectedness, then state the correct reporting action

Describe how safety information flows from a field medical interaction to the safety database and what the field role must and must not do

Explain the core health economics concepts (cost-effectiveness analysis, quality-adjusted life year, budget impact, incremental cost-effectiveness ratio) and interpret a simple cost-effectiveness result

Describe the evidence packages and value dossiers that payers and health technology assessment bodies expect, and identify the questions each section answers

Map the market access pathway from regulatory approval to reimbursement and identify where Medical Affairs contributes

Apply an ethics framework to five stakeholder scenarios (investigator-initiated study request, off-label inquiry, payer meeting, patient advocacy engagement, publication dispute) and justify each decision

State the professional standards governing interactions with healthcare professionals and patients, including transparency and conflict-of-interest disclosure

Explain the publication planning process, including gap analysis, author selection, journal selection, and the role of publication steering committees

Apply authorship and disclosure standards to two scenarios and identify the correct authorship order and required disclosures

Draft a 200-word structured abstract from a supplied study summary, following a background-methods-results-conclusions format

Complete two full-length timed practice exams under exam conditions and record the score by domain

Re-review every domain scoring below 70% and rewrite your condensed notes for each weak area