S.L. 458.47 Art. 18Inspectors.

(1) The inspectors, appointed by the Authority pursuant to Article 15(1) of Directive 2001/20/EC, shall be made aware of and maintain confidentiality whenever they gain access to confidential information as a result of good clinical practice inspections in accordance with applicable Community requirements, national laws or international agreements.

(2) The Authority shall ensure that inspectors:

(a) have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other relevant fields;

(b) have received appropriate training, that their training needs are assessed regularly and that appropriate action is taken to maintain and improve their skills;

(c) have knowledge of the principles and processes that apply to the development of medicinal products and clinical research.

(3) Inspectors shall:

(a) have knowledge of applicable Community and national legislation and guidelines applicable to the conduct of clinical trials and the granting of marketing authorisations; and

(b) be familiar with the procedures and systems for recording clinical data, and with the organisation and regulation of the healthcare system in the relevant Member States and, where appropriate, in third countries.

(4) The Authority shall maintain up-to-date records of the qualifications, training and experience of each inspector.

(5) Each inspector shall be provided with:

(a) a document setting out standard operating procedures and giving details of the duties, responsibilities and ongoing training requirements. Those procedures shall be maintained up to date; and

(b) suitable means of identification.

(6) Each inspector shall sign a statement declaring any financial or other links to the parties to be inspected. That statement shall be taken into consideration when inspectors are to be assigned to a specific inspection.