On 23 October, the Center held a seminar for applicants on the rules for submitting periodic safety update reports (PSURs) for medicinal products. This is the first seminar on this topic in the series of offline pharmacovigilance seminars organized by the Agency for Methodological and Scientific-Practical Work of the SEC.
The event covered in detail:
- regulatory requirements for the preparation and submission of PSURs;
- reflecting information on safety signals in PSURs;
- sources and information search when preparing them;
- the most common mistakes in preparing PSURs and how to avoid them.
Presentations and practical assignments were delivered by specialists of the Division for Monitoring and Management of Safety Information and Evaluation of Periodic Safety Update Reports of the Center’s Pharmacovigilance Department: Maryna Liorynets, Olena Khoromska, Yuliia Fedorets and Nataliia Yevtushenko.
While working with the audience, they drew attention to the deadlines for submitting PSURs, went through specific examples from the practice of benefit/risk assessment of a medicinal product, reviewed in detail the structure of the report, the rules for completing it, and the presentation of specific and reliable data, discussed problematic issues, and answered questions.
The event was chaired by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko. He recalled that the Center is the authorized body for pharmacovigilance of medicinal products and, to assist applicants, holds training seminars in this area on an ongoing basis, and is also launching continuous professional development (CPD) activities. Taking the opportunity, he invited attendees to the first CPD seminar, devoted to current issues of pharmacovigilance, which will take place on October 31 https://m.facebook.com/story.php?story_fbid=pfbid0NpYmpswaVxm8c6PJMEjMThZ3QDfdpvjfJUoQyVWE534Cmxch2ijTLDMwNQ4mpePLl&id=100064542465652
In total, 22 participants joined the seminar. All of them received certificates of training completion.
We would be grateful to participants for feedback and suggestions about the course they attended; these can be sent to the Agency at amsw@dec.gov.ua.
See you at our next events!
