VII.B.7. Training of staff members related to the PSUR process

For all organisations, it is the responsibility of the person responsible for the pharmacovigilance system to ensure that the personnel, including pharmacovigilance, medical and quality personnel involved in the preparation, review, quality control, submission and assessment of PSURs are adequately qualified, experienced and trained according to the applicable guidelines (e.g. ICH E2C(R2) and this GVP Module VII). When appropriate, specific training for the different processes, tasks and responsibilities relating to the PSUR should be in place.

Training to update knowledge and skills should also take place as necessary.

Training should cover legislation, guidelines, scientific evaluation and written procedures related to the PSUR process. Training records should demonstrate that the relevant training was delivered prior to performing PSUR-related activities.