On 27 August 2020, the State Expert Center of the Ministry of Health (hereinafter – the Center) held a webinar on the topic: “Audit of the applicant's pharmacovigilance systems – preparation, conduct, results”.
Taking into account the experience accumulated from the audits of applicants' pharmacovigilance systems already conducted, employees of the Pharmacovigilance Systems Audit Department presented to participants during the webinar reports concerning the main aspects of conducting audits of the applicant's pharmacovigilance system.
During the webinar, participants learned about: the regulatory acts governing the audit of the applicant's pharmacovigilance system; the role of the qualified person responsible for pharmacovigilance/the contact person responsible for pharmacovigilance in preparing for the audit; the factors taken into account when planning an audit; the stages of conducting an audit; audit results and their analysis; approaches to developing and implementing corrective and preventive actions (the Corrective and Preventive Action Plan (hereinafter – CAPA Plan)).
In addition, the most common non-conformities identified during audits were reviewed, and recommendations were provided on preparing for an audit, developing a CAPA plan, and a report on CAPA plan implementation.
During the webinar, participants, who included authorized and contact persons responsible for pharmacovigilance in Ukraine, representatives of companies engaged in pharmacovigilance activities, and employees of other departments of applicants involved in pharmacovigilance, were able to ask questions and discuss topics of interest during the discussion.
Webinar participants received a certificate upon completion.
Since the issues covered during the webinar are currently relevant among a wide range of applicants and their representatives, the Center's next webinar on the topic “Audit of the applicant's pharmacovigilance systems – preparation, conduct, results” is scheduled for 17 September 2020.
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