Pharmacovigilance Audits and Training
We have experience in auditing headquarters, affiliates, partners, distributors, CROs and other providers of pharmacovigilance services for and on behalf of our clients according to GxP and ISO9001.
Our audit methodology is very similar to the approach taken by the European competent authorities when conducting inspections and worldwide accepted audit standards are being used.
We provide training on all aspects of pharmacovigilance to either pharmacovigilance professionals or staff from other departments such as marketing and sales representatives. The training is conducted primarily through workshops tailored to the client’s needs.
We also provide training to investigators participating in clinical trials on adverse event reporting procedures.