On 20 September, a workshop was held at the Center: “The most common non-conformities identified during audits of applicants' pharmacovigilance systems. Example of developing a Corrective and Preventive Action Plan”.
36 participants joined – applicants/representatives of applicants responsible for pharmacovigilance issues, and other interested parties.
The event was opened and the participants were welcomed by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Oleksandr Hudzenko. According to him, the seminar was devoted to special issues of auditing the applicants’ pharmacovigilance systems by the Center as the authorized body. The purpose of the audit is to verify the compliance and effectiveness of the implementation and functioning of the pharmacovigilance system, including its quality system.
Tetiana Bashkatova, Director of the Center's Pharmacovigilance Department, also took part in the opening. According to her, the main goal of the training is to help improve the quality of applicants' pharmacovigilance systems in Ukraine; to raise applicants' awareness of current issues of pharmacovigilance compliance in accordance with the current by-laws and with the application of international standards; and to improve the quality of preparation for audits and the development of proper and effective Corrective and Preventive Action Plans.
The seminar was conducted by qualified pharmacovigilance experts of the Center, who are also auditors certified in accordance with the international standards ISO 19011:2018 “Guidelines for auditing quality management systems” and ISO 9001:2015 “Quality management systems. Requirements”: Mariia Nesterchuk, Kateryna Berezhna, Oksana Hlushchenko, Nataliia Usata.
During the first, theoretical part of the seminar, participants considered the most common non-conformities identified during audits of applicants' pharmacovigilance systems, taking into account the experience of the Center and the regulatory authorities of other countries.
During the second practical part, together with the experts, participants learned to analyze the root causes of nonconformities identified during an audit. Divided into groups, they practiced preparing Corrective and Preventive Action Plans. Together they discussed problematic and most pressing issues that arise in the work of a pharmacovigilance specialist.
The seminar concluded with a ceremonial presentation of certificates.
We remind you that participants can send feedback and suggestions regarding this seminar by completing special questionnaires and sending them to the e-mail address of the Agency for Methodological and Scientific-Practical Work of the Center amsw@dec.gov.ua
For applicants who did not manage to register for the seminar in time, a repeat session is possible (for registration issues, contact the Agency at amsw@dec.gov.ua)
