The Center held a seminar for applicants on managing safety information on medicinal products. The training program covered everything about introducing safety-related changes to the registration dossier materials based on the results of implementing the post-registration development plan for a medicinal product and carrying out pharmacovigilance.
The seminar on this topic in the series of pharmacovigilance issues took place for the first time within the External Training Program under the guidance of the Methodological and Scientific-Practical Work Agency of the Center. The aim is to help maintain a positive benefit/risk balance of medicinal products in the post-registration period through timely introduction of safety-related amendments in accordance with legislative requirements.
26 participants took part – representatives of applicants, registration certificate holders, and developers and manufacturers of medicinal products.
The head of the Agency, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko, gave the opening remarks at the event. He presented the purpose and objectives of the seminar, the program, and the speakers. Taking the opportunity, he invited participants to join the seminars held by the Center within the continuing professional development (CPD) program, in order to deepen professional competencies and earn the points required for certification.
According to the seminar program, the theoretical and practical parts of the course were delivered by specialists of the Center:
In her presentation, Yevheniia Skoryk outlined the prerequisites and consequences of making changes to the registration dossier (RD) during the life cycle of a medicinal product. She reminded the audience of the types of changes. Using real examples and statistical data, she emphasized the importance of making safety-related changes to maintain a positive benefit/risk balance of the medicinal product. She stressed the importance of reporting adverse reactions and of making safety-related changes to the instructions for medical use of the medicinal product.
Halyna Druk explained in detail the issue of Type I safety variations: the grounds and the deadlines that must be observed.
Maria Shtyfurak informed participants about the grounds and deadlines for introducing amendments/additions to the package insert of a medicinal product under a type II variation, emphasizing the importance of timeliness.
During the practical part of the course, together with the lecturers, participants worked through case scenarios on selecting the type of variation, completing the registration form, and compiling the dossier. They analyzed difficult cases from practice and received answers to their questions.
The seminar concluded with the presentation of certificates.
The Agency for Methodological and Scientific-Practical Work will be grateful to participants for feedback and suggestions on the content and quality of the training provided amsw@dec.gov.ua
Please note that current pharmacovigilance issues will also be covered at the upcoming online seminar to be held at the Center on 22 November as part of the Professional Development Training Program. Details and registration here https://bpr.dec.gov.ua/ We invite you to join!
