Competent Authorities regularly exchange information about the non-compliance and regulatory actions taken against Marketing Authorisation Holders.
Marketing Authorisation Holder's are expected to monitor their pharmacovigilance systems and processes for compliance with regulatory guidelines. These activities should be carried out separate to or in preparation for a regulatory inspection.
External CAPA (Corrective & Preventative Actions) Audits can be requested to review your company's or your current provider of Medical Information handling and Pharmacovigilance functions.
At Red Line we can assist you in this process and help to ensure a robust system of Pharmacovigilance is in place by thorough analysis of your detailed description of pharmacovigilance, safety reports and standard operating procedures.