MAB Registration Exam study guide
MAB Registration Exam · Work through your exam, one topic at a time.
The MAB Registration Exam (also described as the Medical Affairs Board Registration Examination or MAB Certification Exam) is a multiple-choice credential aimed at professionals working in, or moving into, medical affairs within the life sciences industry. It is designed for medical science liaisons, medical information specialists, medical advisors, publication and medical communications staff, and adjacent roles such as regulatory, pharmacovigilance, and market access professionals who need a structured grasp of how medical affairs operates. The MAB Registration Exam study guide has 10 sections and about 3,152 words.
01Medical Affairs Fundamentals and the Role of Medical Affairs in the Life Sciences Industry
This section examines how medical affairs (MA) is positioned inside a biopharma or device company, what its sub-functions do, and why it is deliberately separated from commercial. Expect questions on the non-promotional mandate, lifecycle activities, medical review and sign-off of materials, and transparency obligations.
341 words, about 2 min02Drug Development Process and Clinical Research
This domain tests your command of the development cascade from discovery to post-approval, the vocabulary of trial design and biostatistics, and GCP obligations. Questions often ask you to read a result and state what can and cannot be claimed.
312 words, about 2 min03Regulatory Affairs and Compliance
This section covers approval pathways, labelling, and the line between permissible scientific exchange and prohibited promotion, plus the anti-corruption rules that shape field activities. US pathways: IND; NDA under 505(b)(1) (own full data) or 505(b)(2) (reliance on literature or another's findings); BLA for biologics; ANDA for generics.
316 words, about 2 min04Medical Information and Scientific Communication
Medical information (MI) is the company's controlled channel for unsolicited scientific requests. The exam checks that you know the workflow, documentation standards, safety-reporting handoff, and how a non-promotional response differs from a promotional one.
311 words, about 2 min05Medical Science Liaison and Field Medical Activities
Field medical is where compliance risk is highest and where the exam tests role boundaries most heavily: scientific exchange with experts, insight capture, trial site support, and the prohibitions that define the role. The MSL's currency is scientific exchange with external experts: disease state, data, guidelines, safety, and the evidence gaps relevant to the product's lifecycle.
323 words, about 2 min06Clinical Development and Evidence Generation
This domain covers how companies close evidence gaps beyond the pivotal programme: investigator-initiated studies, real-world evidence, registries, patient-reported outcomes and expanded access. Expect questions on which evidence answers which question and its limitations.
315 words, about 2 min07Pharmacovigilance and Drug Safety
This domain tests whether you recognise a safety case in any setting and know the reporting mechanics: definitions, minimum criteria, timelines, aggregate reports and risk management. An adverse event is any untoward medical occurrence; an adverse drug reaction is one with reasonable causal relationship.
318 words, about 2 min08Health Economics, Outcomes Research, and Market Access
This domain covers the evidence payers use to decide price and access: cost-effectiveness, budget impact, health technology assessment, and the formats in which value is communicated. Economic evaluation types: cost-minimisation (equal outcomes), cost-effectiveness (natural units, e.g.
299 words, about 1 min09Ethics, Professionalism, and Interactions with Stakeholders
This domain tests judgment: whether an interaction with an HCP, patient organisation or vendor withstands scrutiny under codes, anti-bribery law and transparency rules. Governing instruments: PhRMA Code, EFPIA and IFPMA codes, AdvaMed for devices, Open Payments/Sunshine reporting, Anti-Kickback Statute, False Claims Act, FCPA and UK Bribery Act, GDPR and HIPAA.
310 words, about 2 min10Publication Planning and Scientific Writing
This domain tests how industry-sponsored science reaches the literature legitimately: authorship criteria, planning, reporting standards, review, and the ethical failures that examiners love to test. ICMJE authorship requires all four: substantial contribution to conception/design or acquisition/analysis/interpretation; drafting or critical revision; final approval of the version submitted; and accountability for the work.
307 words, about 2 min