The Center held a seminar for applicants devoted to special issues of auditing a pharmacovigilance system. The training was organized by the Agency for Methodological and Scientific-Practical Work as part of the Center's External Training Program.
The purpose of the seminar is driven by legislative requirements, since a marketing authorization applicant for medicinal products establishes, ensures and guarantees the functioning of a pharmacovigilance system, which is a mandatory condition for the circulation of medicinal products, vaccines and tuberculin in the territory of Ukraine.
During the seminar, participants together with the speakers:
- became familiar with the types of non-compliances identified during audits of applicants' pharmacovigilance systems – the experience of the Center and regulatory authorities of other countries;
- reviewed the most common non-conformities identified by the Center during inspections, using practical examples;
- identified the reasons for their occurrence and cause-and-effect relationships;
- learned how to correctly and effectively prepare Corrective and Preventive Action Plans (Corrective and Preventive Action Plan).
The speakers were highly qualified State Expert Center pharmacovigilance experts who are also auditors certified in accordance with international ISO standards: Mariia Nesterchuk, Kateryna Berezhna, Nataliia Usata, and Oksana Hlushchenko.
The event was opened by the Head of the Agency, Doctor of Pharmaceutical Sciences, Professor, Honored Worker of Health of Ukraine Oleksandr Hudzenko.
In his welcoming speech he greeted the participants and presented the purpose, the Program and the speakers of the seminar. He separately drew the attention of those present to the importance of continuous professional development (CPD) of health care workers and called on them to join the CPD trainings held by the Center. He emphasized that each CPD training at the Center is an opportunity to receive not only narrow professional information from the Center’s specialists, but also the points needed for the attestation of physicians and pharmacists.
During the first part of the seminar, participants, together with Kateryna Berezhna, expert of the Division for Audit of Applicants' Pharmacovigilance, reviewed the main reasons for conducting targeted audits and the most common non-compliances identified during them, drawing on the experience of the Center and regulatory authorities of other countries.
Together with experts of the applicants' pharmacovigilance audit division, Oksana Hlushchenko and Nataliia Usata, they reviewed the regulatory requirements governing audits and the principles of the applicant's oversight of the performance of critical pharmacovigilance processes.
Together with the head of the Department, Mariia Nesterchuk, we learned about the stages of implementing an effective plan of corrective and preventive actions. We examined the causes of nonconformities and the techniques used to analyze the causes that led to a particular problem. We also reviewed typical mistakes that arise when developing a plan of corrective and preventive actions.
During the practical part, together with the course lecturers, we practiced developing a Corrective and Preventive Action Plan and examined in detail the problematic and most relevant issues that arise in its development.
The Center's external trainings are certified – after the seminar, all participants received the relevant certificates.
We draw applicants' attention to the fact that in November the Center will hold 6 more external offline trainings on various aspects of its activities, as well as 1 seminar in the PD area on current issues of pharmacovigilance. Learn more https://m.facebook.com/story.php?story_fbid=pfbid02JwajcPoVjggFrCrwVhEpDHdyFuRG3K8LV3s5xh9hgMkmLMofteSTpSFifWoDkEtrl&id=100064542465652
For registration matters, contact the Agency for Methodological and Scientific-Practical Work (044) 202-17-00 (2251), amsw@dec.gov.ua
