Reply to Thread
We have had an inspection from a regulatory authority on PV, and we have been challanged with our case handling processes. The inspector has raised a consern regarding our use of a veterinary as a case processor. the inspector requestes that all cases entered by the veterinary qualified person are to be reviewd by a medical person before being reported. Any comments form anyone? and who would be medically qualified to do so? only medical doctors, or also nurses and pharmacists? Kr Nina
Hi Nina, The question does not provide sufficient detail as to the responsibilities assigned to the case processor (were they reviewing for human medical sense? or whether the product was for veterinary or human medical use?). If the product was for veterinary use but could pose a risk to humans, a Veterinarian would not/may not have the relevant qualifications to evaluate the data from a human medical standpoint and hence this would be of concern to the regulators. As to who would be medically qualified to do a medical review, this would also be dependent on the type of product and relevant Regulatory requirements for medically qualified personnel e.g. in the UK a Nurse Practitioner may be considered as able to medically evaluate the data. The relevant Regulatory Authorities would be able to clarify their requirements in this regard.