Role-based pharmaceutical compliance training matrix

Start with work, responsibilities and risk

List the activities your teams actually perform: creating materials, meeting healthcare professionals, arranging events, selecting consultants, processing payments and handling disclosure data. Include contractors and agencies in that exercise. Job titles alone are a poor guide when one person covers several functions.

For each activity, identify the decision the learner must make, the procedure they use and the point at which they must seek help. A useful learning objective is observable: a meeting organiser can recognise missing approval evidence and stop the booking. ‘Understand compliance’ is too broad to assess.

Agree the matrix with function owners before assigning courses. Record the market, module version, required learning depth, assessment method and accountable owner. Keep a short explanation where a topic is not relevant to a role so that later changes can be evaluated.

Suggested role-to-topic matrix

Use awareness for recognising an issue and escalating it, applied learning for carrying out a task, and specialist learning for evaluating difficult cases. These labels describe depth of learning. They do not confer approval authority.

Connect the plan to the UK Code

For activities within its scope, ABPI Code Clause 9.1 covers relevant staff and contractors preparing or approving materials or activities. Clause 9.2 requires work-relevant pharmacovigilance knowledge to be documented. Representatives also have scientific-training and examination requirements under Clauses 9.3–9.5. In particular, the appropriate examination must be taken within the first year and passed within two years, subject to the Code’s detailed provisions.

Use the linked Code to confirm applicability and examination arrangements. The matrix supports your planning process; it does not replace specialist qualification requirements. Assign pharmacovigilance learning relevant to each person’s work alongside the commercial compliance topics.

Choose learning and assessment together

Pair each module with a realistic task. A short introduction may be sufficient for awareness, while an operational role may need a workshop, supervised practice and feedback. Reviewers may need calibration sessions to compare how they interpret the same example.

Define what a satisfactory response looks like before delivery. Ask learners to explain the decision, locate the procedure and identify the evidence they would retain. Where a response is incomplete, record the gap, follow-up activity and reassessment. Attendance and a course completion flag should not be treated as proof of practical competence.

• Use examples from the learner’s market and channel, with confidential details removed.
• Agree who assesses each exercise and how inconsistent judgements are resolved.
• Provide a route for questions after training, especially during a new process rollout.
• Use findings from routine work to improve the next version of the learning material.

Set refresh triggers and keep useful records

Agree refresh arrangements according to risk, role changes, new products or markets, amended procedures and monitoring findings. Do not assume that one annual course is the right answer for every topic. A targeted update after a workflow change may be more useful than repeating an unchanged module.

Keep the role assignment, module version, completion date, assessment outcome and outstanding actions in your approved learning system. Review overdue assignments with the manager and process owner. Decide how any restriction on independent work is recorded and communicated under company policy.

Monitor a small set of meaningful measures: recurring errors after training, the quality of first submissions and whether escalations reach the right owner. Compare like activities and explain changes in workload before attributing an improvement to training alone.

Use the editable matrix

The workbook provides topic rows and role columns with suggested learning levels. Adapt those assignments first, then use the training-plan sheet for one role and module per row. Add owners, delivery methods, dates and evidence references. The example plan row is labelled and should be replaced before operational use.

Save your completed copy in an approved internal location. Entries are not sent to Eunomia. The workbook supports planning and tracking; it does not calculate a compliance score or automatically approve anyone for a role.

The people behind the support

Explore the roles and experience of Eunomia’s compliance team and identify the expertise relevant to your markets and operating model.