PPB Pharmacist Pre-registration Exam study plan

Map the full MA lifecycle from pre-submission to post-authorisation variation, listing each regulatory step and its required documentation in your own notes

Distinguish national, decentralised, mutual recognition and centralised procedures, and state which application type fits three given product scenarios

Classify five example product changes as Type IA, Type IB or Type II variations and justify each classification

Explain the structure and purpose of the Common Technical Document modules and identify which module holds quality, safety and efficacy data

Draft a one-page checklist of the dossier sections a candidate would expect to see in a new marketing authorisation application

Link MA dossier quality requirements to the pharmacopoeial and specification controls that support them

Describe how active substance and finished product specifications are set, including acceptance criteria and justification

Explain validation of analytical methods by listing the parameters assessed and when revalidation is triggered

Outline the lot release pathway for a biological product and identify which tests require independent laboratory confirmation

Compare in-house, contract and official control laboratory roles in release testing

Interpret out-of-specification and out-of-trend results and describe the investigation sequence expected before a batch decision

Explain stability study design, including bracketing and matrixing, and state what shelf-life claims they support

Prepare for an inspection by listing the documentation an inspector would request in a quality control laboratory

Describe how inspection findings are graded, from critical to minor, and outline a corrective and preventive action plan for one critical finding

Identify the difference between routine, for-cause and pre-approval inspections and what triggers each

Map the licensing requirements for a pharmacy premises, including the responsible pharmacist role and conditions attached to a licence

Explain good pharmacy practice standards for dispensing, storage, cold chain and record keeping, and self-audit against them

Build a personal CPD cycle, recording a learning need, planned activity, reflection and outcome for one real activity

Describe how training records and competence assessments are evidenced during an inspection

State the actions a responsible pharmacist must take when a licence condition is breached or a serious incident occurs

Outline the clinical trial authorisation route, listing the submissions and approvals needed before first participant in

Explain the roles and legal responsibilities of sponsor, investigator, monitor and ethics committee across a trial

Apply informed consent requirements to two scenarios, including a vulnerable participant, and state what makes consent valid

Describe good clinical practice requirements for source data, case report forms and investigational product accountability

Classify three safety events as adverse event, serious adverse event or suspected unexpected serious adverse reaction and state the reporting timelines

Describe the pharmacovigilance system and its quality requirements, including the role of the qualified person responsible for pharmacovigilance

Distinguish individual case safety reports from periodic safety reports and state the reporting timelines and routes for each

Explain signal detection and how a signal is validated, prioritised and followed by regulatory action

Describe risk management plans and risk minimisation measures, giving one example of routine and one of additional measures

Trace the actions following a serious safety concern, from assessment through variation, suspension or withdrawal

Explain market surveillance activities, including sampling and testing programmes, and how non-compliant products are handled

Describe the recall classification system and outline the steps and timelines for a recall from notification to effectiveness check

Identify the falsified medicine risks and the checks used to verify a suspicious product

Navigate the online regulatory systems used for applications, submissions and safety reporting, and list the data fields each requires

Explain how electronic systems support traceability, including batch and product identification, and what a data integrity failure would look like

Synthesise all domains by writing short answers to two integrated scenarios that each span at least three domains

Revisit your weakest two domains using your own notes and correct any factual errors found

Complete a timed mixed-domain practice set and review every incorrect answer to its source rule

Consolidate a one-page summary sheet of key timelines, thresholds and reporting routes for final revision

Confirm exam-day logistics and rehearse the summary sheet from memory