The Center held a workshop for applicants, "Documents Accompanying a Medicinal Product: Package Leaflet, Summary of Product Characteristics, Packaging Labeling. Current Requirements and Ways to Resolve Problematic Issues."
The purpose of the training is to deepen awareness of the requirements for the official materials accompanying a medicinal product.
The audience became familiar with important aspects such as:
- the trade name of a medicinal product and criteria for its acceptability;
- preparing the instructions for medical use of a medicinal product: requirements, structure, specifics of presenting information;
- grammatical errors and ways to avoid them when composing text;
- summary of product characteristics: the present and the future;
- requirements for labeling the packaging of a medicinal product;
- a technical error and the options for correcting it in approved documents;
- requirements for registration dossier materials when carrying out the variation procedure;
- criteria for determining medicinal products whose advertising is prohibited.
The speakers were specialists and experts of the Division for Expert Evaluation of Materials on Medical Use of Medicinal Products and Nomenclature of the Department for Expert Evaluation of Registration Materials (DERM) of the Center, led by the Head of the Division, Viktoriia Chernenko.
Participants had the opportunity to discuss specific cases from their work experience, ask questions that arise during registration, re-registration, and variation procedures, and practice solving case-based tasks. Our specialists emphasized the Center's openness to dialogue and cooperation with applicants and its readiness to provide consultations.
The workshop was supervised by Oleksandr Hudzenko, Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor, Honored Health Worker of Ukraine.
According to him, the Center's specialists have a truly high level of professional competence to provide a sufficient amount of information and practical skills that can guarantee that applicants obtain the proper level of knowledge on procedural issues. It was emphasized that the Methodological and Scientific-Practical Work Agency of the Center always issues certificates of completion of training.
O. Hudzenko recommended that medical and pharmaceutical professionals take part in continuous professional development events at the State Expert Center as a professional development provider https://bpr.dec.gov.ua/
