PPB Pharmacist Exam study plan

Map the full MA lifecycle from pre-submission to post-authorisation variation, writing a one-page flow diagram from memory by end of week.

List the mandatory dossier modules and the country-specific administrative documents required at submission, and state for each what triggers a rejection versus a query letter.

Distinguish the registration pathways available (full dossier, abridged, reliance/recognition, emergency use) and give one realistic product scenario for each.

Create a personal account on the national online submission portal and walk through a dummy application form field by field without submitting.

Draft five practice questions on MA validity, renewal cycles and transfer of ownership, then answer them closed-book.

Build a checklist of what an inspector reviews in a retail pharmacy, covering premises, storage, documentation, and staff records.

Explain the difference between routine, for-cause and follow-up inspections, and predict what each type would prioritise in the same pharmacy.

Write model corrective and preventive action (CAPA) entries for three common deficiencies, each with an owner and a realistic timeline.

Rehearse a 10-minute opening interview in which you present your quality manual to an inspector, out loud.

Classify ten sample findings as critical, major or minor and justify each classification in one sentence.

Summarise Good Pharmacy Practice requirements for dispensing, counselling, and premises in your own words, capped at two pages.

Draft a personal CPD plan for the next 12 months with three learning goals, chosen activities, and evidence you will retain for each.

Compare the roles and liabilities of the superintendent pharmacist, the responsible person, and the quality controller in a single comparison table.

Design a 45-minute induction training module for new dispensing staff, including a knowledge check with an answer key.

Identify which tasks may be delegated to pharmacy technicians and which must remain with the pharmacist, citing the principle behind each boundary.

Sequence the clinical trial approval steps from protocol development to first participant enrolled, noting which body approves what.

Explain informed consent requirements, including the elements of the participant information sheet and the handling of vulnerable populations.

Outline sponsor, investigator and ethics committee responsibilities and identify three situations that require a substantial amendment.

Describe safety reporting timelines for serious adverse events and suspected unexpected serious adverse reactions, and calculate two worked examples.

Draft a monitoring plan outline for a small single-site trial, listing source data to verify and the frequency of visits.

Describe how products enter the market surveillance sampling programme and what happens to a sample from collection to laboratory result.

Explain recall classification and the decision steps for a Class I, II or III recall, including who is notified and within what timeframe.

Walk through lot release: what a lot release certificate covers, which products need it, and what documentation the manufacturer submits.

Outline the quality control tests performed on a finished oral solid dosage form and state the acceptance criterion concept for each.

Interpret two short out-of-specification scenarios and decide whether an investigation, a recall, or no action is warranted, with reasons.

Define the minimum criteria for a valid individual case safety report and identify which four elements are essential.

Classify ten sample adverse event reports by seriousness and expectedness, and state the reporting route and deadline for each.

Explain signal detection and what happens after a signal is validated, including the possible regulatory actions.

Describe the periodic safety report types, their scope and their submission frequency, and note one common error in each.

Draft a 200-word patient counselling script on reporting side effects, pitched at a person with no medical background.

Navigate the main regulatory online systems end to end and record the exact steps for three routine tasks you will need on the job.

Explain what each system is for and who has access, distinguishing applicant, assessor and public-facing functions.

Practise submitting a variation through the portal in a training environment and list the five most common data-entry errors that cause rejection.

Revisit MA variations and renewals and connect each to the specific online transaction that implements it.

Build a troubleshooting guide for three realistic portal failures, such as a rejected file format or an expired digital certificate.

Complete two full-length timed mock exams under exam conditions and record your score per domain.

Rank your eight domains by mock score and re-study the two weakest for at least two hours each.

Compile a one-page formula and timeline sheet covering reporting deadlines, recall classes and renewal cycles, and memorise it.

Write and answer 24 rapid-fire recall questions, three per domain, without notes.

Review every question you answered incorrectly across the plan and write the correct principle in your own words for each.