Clause 16 - Training
16.1 All relevant personnel including representatives and members of staff, and others retained by way of contract, concerned in any way with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
16.2 All personnel (and others retained by way of contract) must be fully conversant with pharmacovigilance requirements relevant to their work and this must be documented.
16.3 Representatives must take an appropriate examination within their first year of employment as a representative and must pass it within two years of starting such employment.
To be acceptable, an examination must have been accredited to at least Level 3 by an external awarding body recognised by Ofqual.
An appropriate examination for medical representatives is one that requires a broad understanding of body systems, diseases and treatments, the development of new medicines and the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be a Diploma (at least 37 credits or equivalent learning hours).
An appropriate examination for generic sales representatives is one that requires a broad understanding of body systems, the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be a Certificate (at least 13 credits or equivalent learning hours).
An appropriate examination can be either the relevant ABPI examination (for medical or generic sales representatives) or an examination of at least the same standard as the ABPI examinations and covering similar content and learning material as the corresponding ABPI examination.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
16.4 Details of the numbers of representatives who have passed an examination, together with the examination status of others, must be provided to the Prescription Medicines Code of Practice Authority on request.