III.B.9. Qualification and training of inspectors

Inspectors who are involved in the conduct of pharmacovigilance inspections requested by their Member States or by the CHMP should be officials of, or appointed by, the Member State in accordance with national regulation and follow the provisions of the national competent authority.

It is recommended that inspectors are appointed based upon their experience and the minimum requirements defined by the national competent authority. In addition, consideration should be given to the recommendations for training and experience described in the compilation of Union procedures on pharmacovigilance inspections mentioned in III.B.5.

The inspectors should undergo training to the extent necessary to ensure their competence in the skills required for preparing, conducting and reporting inspections. They should also be trained in pharmacovigilance processes and requirements in such way that they are able, if not acquired by their experience, to comprehend the different aspects of a pharmacovigilance system.

Documented processes should be in place in order to ensure that inspection competencies are maintained. In particular, inspectors should be kept updated with the current status of pharmacovigilance legislation and guidance.

Training and experience should be documented individually and evaluated according to the requirements of the applicable quality system of the concerned competent authority.