The purpose of the training is to provide up-to-date information on typical non-conformities identified during audits of applicants' pharmacovigilance systems, to familiarize participants with practical approaches to developing and implementing a Corrective and Preventive Action Plan (CAPA), and to contribute to improving the effectiveness of pharmacovigilance systems and their compliance with regulatory requirements.
The knowledge gained will help participants improve internal pharmacovigilance processes and increase readiness for regulatory audits.
The following are invited to participate: applicants/applicant representatives, pharmacovigilance professionals, regulatory affairs managers, and other representatives of pharmaceutical companies.
Format: mixed (offline/online)
Date: July 31, 2026
Venue: Kyiv, Simi Brodskykh St., 10, the Center's premises/ZOOM platform
Speakers: specialists of the Directorate for Audit of Clinical and Preclinical Studies and Pharmacovigilance Systems of the Center
In the programme
- Targeted audits of applicants' pharmacovigilance systems. Results. Types of non-conformities
- The most common nonconformities identified during the audit of the applicants’ pharmacovigilance system, with examples from practice
- Plan of corrective and preventive actions (Corrective and Preventive Action Plan) – from development to implementation
- TOP recommendations/comments on the Corrective and Preventive Action Plan
- Practical cases
PROGRAM
Certificate: after participating in the seminar, each participant will receive a certificate.
Registration
to participate, you need to fill in the application and send it in electronic form in doc / docx format to the organizers – the Agency for Methodological and Scientific-Practical Work of the Center: amsw@dec.gov.ua, tel.: +38 (044) 202-17-00 (2251, 2253)
Join us to deepen your knowledge, exchange experience, and receive practical recommendations from leading industry experts! We will be glad to have you with us!
