MAB Registration Exam flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Medical Affairs core mandate

A non-promotional function responsible for scientific exchange, evidence generation and dissemination, medical information, and medical review, operating separately from commercial targets to ensure fair-balanced, evidence-based communication.

Fair balance

The requirement that benefit claims be presented together with the most serious and most common risks, with comparable prominence and readability, in promotional and medical materials.

Open Payments

A US transparency program requiring manufacturers to report transfers of value to physicians and teaching hospitals, such as consulting fees, meals, travel, and research payments, for public disclosure.

Phase I objective

The first-in-human stage, typically 20 to 100 subjects, assessing safety, tolerability, pharmacokinetics, and maximum tolerated dose, often in healthy volunteers or selected patients.

Intention-to-treat analysis

An analysis including all randomized participants in their assigned groups regardless of adherence or withdrawal, preserving randomization and giving a conservative estimate of effect.

Surrogate endpoint

A laboratory or imaging measure, such as viral load or blood pressure, used as a substitute for a clinical outcome when it is validated or accepted as predictive of benefit.

505(b)(2) pathway

A US application for a changed version of an approved drug that relies in part on published literature or prior agency findings rather than the applicant's own full preclinical and clinical data.

Accelerated approval

A US pathway granting approval based on a surrogate or intermediate endpoint reasonably likely to predict benefit, conditioned on confirmatory post-marketing trials.

Orphan drug designation

US status for drugs treating diseases affecting fewer than 200,000 patients, providing incentives such as market exclusivity and tax credits for development.

CTD Module 3

The quality section of the Common Technical Document containing chemistry, manufacturing, and controls information, including drug substance and drug product data.

Standard response letter

A pre-approved, referenced medical information document answering a specific unsolicited question, version-controlled and re-reviewed when new data or safety information emerge.

Unsolicited request rule

Medical Information may answer an unsolicited question about an unapproved use with balanced scientific data in a private setting, but may not proactively promote that use.

Adverse event triage

The process of identifying safety reports and product quality complaints within incoming medical information inquiries and forwarding them immediately to pharmacovigilance or quality units.

MSL non-promotional role

A field-based scientific expert who exchanges peer-to-peer data with external experts, does not sell, and holds no sales quota or promotional targets.

Key external expert selection

Choosing advisors and field contacts based on scientific expertise, publications, and trial experience rather than prescribing volume, with documented rationale and disclosed compensation.

Investigator-initiated study

A study designed, conducted, and sponsored by an investigator, with the company providing drug or funding after independent scientific review while the investigator retains control.

Real-world evidence

Evidence on use, benefits, and risks derived from routine-care data such as registries, claims, and electronic health records rather than controlled trial settings.

Evidence gap analysis

A structured comparison of the target product profile against available data to prioritize studies addressing missing comparative, special-population, or long-term safety evidence.

Serious adverse event

An event causing death, being life-threatening, requiring hospitalization or prolongation, causing persistent disability, congenital anomaly, or another medically important occurrence.

SUSAR reporting timeline

Serious, unexpected suspected adverse reactions require expedited reporting, generally within 7 calendar days for fatal or life-threatening cases and 15 days for other serious cases.

Signal detection

The process of identifying new or changed safety information from spontaneous reports, trials, literature, and databases, using disproportionality measures as screening rather than causal proof.

Risk management plan

A regulatory document describing a product's known safety concerns, planned pharmacovigilance activities, and risk minimization measures such as restricted distribution or educational materials.

Incremental cost-effectiveness ratio

The difference in cost between two interventions divided by the difference in health effect, commonly expressed as cost per quality-adjusted life year gained.

Quality-adjusted life year

A health outcome metric multiplying time in a health state by a utility weight from zero, equivalent to death, to one, equivalent to perfect health.

Budget impact analysis

An estimate of the financial consequence to a payer of adopting a new intervention over a defined period, accounting for eligible population, uptake, and cost offsets.

Health technology assessment

A formal evaluation by bodies such as NICE or CADTH of a technology's clinical and cost effectiveness to inform reimbursement and coverage decisions.

Fair-market-value compensation

Payment to advisors or speakers set at the rate a qualified professional would command for comparable services, documented and independent of prescribing behavior.

Advisory board requirements

A documented scientific need, expert selection by expertise, an agenda and minutes, fair-market-value honoraria, and restricted commercial attendance to preserve non-promotional purpose.

Declaration of Helsinki

A World Medical Association statement of ethical principles for human research, requiring independent ethics review, informed consent, and protection of vulnerable participants.

ICMJE authorship criteria

Four conditions: substantial contribution, drafting or critical revision, final approval, and accountability, all of which must be met for authorship credit.

Ghost authorship

Omission of a professional medical writer who made substantial contributions, a practice that violates authorship transparency standards and requires acknowledgment and funding disclosure.

CONSORT statement

Reporting guidelines for randomized controlled trials specifying required elements such as randomization, blinding, participant flow, and outcome reporting to enable critical appraisal.