Training & Courses
SOP training and pharmacovigilance training for everyone in the company who may learn of a suspected case.
What do training and courses achieve?
Pharmacovigilance training teaches what a reportable matter is, how it must be passed on and which deadline it starts. This is complemented by SOP training for the people who actually carry out the processes — each with documented evidence.
Why does it matter?
The reporting deadline starts as soon as anyone in the company becomes aware of a case. This makes sales, field force, reception, marketing and customer service part of the pharmacovigilance system, whether the organisation chart says so or not. Training only the specialist department leaves the most common source of error unaddressed. Missing or undocumented training is a standard finding in inspections.
Who needs it?
Marketing authorisation holders with new staff or revised SOPs. Companies facing an inspection. And all those whose training records are incomplete or whose last training took place longer ago than the last process change.
What do the regulations require?
- GVP Module I — qualification and training of personnel, maintenance of training records
- Training obligation on recruitment and with every relevant process change
- Training records as a subject of audits and inspections
- GVP Module IV — training status as part of the audited system
How VigiPRO supports you
- SOP training for the users of the respective processes
- Basic pharmacovigilance training for staff with external contact
- In-depth training for pharmacovigilance teams, for example on single case assessment or signal management
- Refresher training after process changes and before inspections
- Training materials and records in auditable form
Why VigiPRO
Training is based on your processes, not on a generic slide deck. Those who write SOPs themselves and support inspections know where cases are actually lost in day-to-day work.
Frequently asked questions
Who needs to be trained?
Everyone who may learn of a suspected case in the course of their work. That extends well beyond the pharmacovigilance department and includes sales, field force and customer contact.
How often is refresher training required?
No fixed interval is prescribed. Event-driven training is mandatory: on recruitment, on a change of role and with every relevant process change. Many companies add an annual refresher.
Is an attendance list sufficient as evidence?
What has to be demonstrated is who was trained on which content and when — usually through a training plan, materials, confirmation of attendance and, depending on the topic, a knowledge check.
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