PPB PharmTech study plan

Map every module of the online portal ecosystem (submission gateways, product/lot databases, safety reporting interfaces, inspection and licensing portals) and write a one-line purpose statement for each

Walk through the full lifecycle of a new marketing authorisation application in the portal environment, from account creation and dossier upload to validation feedback and approval tracking

Draft a one-page glossary of MA terminology (variation, renewal, mutual recognition, reference member state, dossier modules) and test yourself until recall is fluent

List the document types and file formats each portal accepts, and note where submissions commonly fail validation

Trace how a laboratory result or lot release certificate enters the online system and how it becomes visible to regulators and the public

Explain the difference between marketing authorisation holder testing, official control laboratory testing, and independent batch certification, and state when each applies

Build a checklist for reviewing a certificate of analysis (identity, assay, impurities, dissolution, microbial limits, method validation status, retest date)

Practise interpreting out-of-specification and out-of-trend results and describe the investigation sequence that follows

Describe the full signal management cycle (data collection, detection, validation, assessment, risk minimisation, communication) and locate where each step happens in the online reporting tools

Classify adverse event reports by seriousness, expectedness, and causality, and state the reporting timelines attached to each category

Draft a periodic safety report outline that covers the required sections and the data sources you would pull from the portals

Explain recall classification and market withdrawal procedures, and outline the steps from defect detection to public communication

Compare the roles of the marketing authorisation holder, the national competent authority, and the regional harmonisation body in post-market surveillance

Assemble a mock inspection preparation pack: document index, site master file summary, deviation log, and training records list

Write model answers to the ten most likely inspection questions on data integrity, qualification and validation, and laboratory controls

Explain how inspection findings are graded and what a corrective and preventive action plan must contain to close each grade

Describe how inspection outcomes are recorded and published in the online systems, and what a failed inspection triggers

Sequence the clinical trial application process from protocol development to first-patient-in, naming the approvals and notifications required at each step

Summarise the investigator's and sponsor's safety reporting duties during a trial, including expedited reporting and annual reporting

Distinguish the roles of the ethics committee, the regulator, and the data safety monitoring board in trial oversight

Explain what happens to trial data and safety reports after authorisation, and how they feed into ongoing vigilance

Map the licensing requirements for a pharmacy or wholesale establishment: premises, personnel, documentation, and storage conditions

Describe good pharmacy practice expectations for dispensing, counselling, and record keeping, and identify the records that must be retained and for how long

Build a personal continuing professional development plan with three learning goals, evidence sources, and a reflection format

Explain how training records and competence assessments are verified during inspection, and what evidence a candidate should be able to produce

Work through two full scenario cases that begin with a variation application and end with a safety-driven label change, documenting each regulatory touchpoint

Rehearse the decision logic for when a variation requires prior approval versus notification only

Draft a risk minimisation plan for a hypothetical product with a newly identified safety concern, including communication and effectiveness measurement

Explain how post-market commitments and conditions attached to an authorisation are tracked and evidenced in the online systems

Complete a full timed mock exam under exam conditions and record your score by domain

Re-study only the two domains with the lowest scores, focusing on the specific question types you missed

Rehearse portal navigation tasks under time pressure: locating a submission, checking a lot release status, filing a safety report

Write a one-page exam-day strategy covering question order, time allocation, and how to handle unfamiliar portal scenarios