The course “CTD module 3 – Quality (EU). Medicinal products for Human use” is of the overview nature and introduces to the big subject of final drug product quality in the registration dossier of medicinal product in the EEA. The presentation may be very useful for those who start working on the preparation of registration dossiers in terms of the quality of a final drug product (module 3.2.P) for the European market or as manufacturers of “license” drug products intend to start cooperation with marketing authorization holders operating on the European market. The course can also be addressed to employees working in regulatory, quality control, development research or production, as well as project managers.
If the trainee is interested in basics concerning the Common Technical Document (CTD) format, what is it, when and where it is binding and what is e-submission and how the main structure of the CTD format look like, this introduction may be found in the twin course dedicated to active substance: “CTD module 3 – Quality (EU). Active Pharmaceutical Ingradient (API) / Drug Substance in medicinal products for Human use”. As part of introduction, in the abovementioned presentation, the previous format of the NtA documentation is also discussed. Thanks to this, the course participant can understand what is the role and purpose of using CTD format and what are the related obligations.
The exact structure of the final drug product quality module is then discussed. Section by section of the CTD, the trainee will learn what information is included in the subsequent sections of the module. It is crucial to know where the module on the quality of the active substance ends and where the medicinal product begins. This is also presented exhaustively in the previously mentioned course, which may be even more useful for those who are more interested in module 3.2.P.
The next part of the training is a discussion about legal basis and types of procedures in terms of module 3 and whether quality information is anyhow affected by the submission basis.
The annexes to the Application Form should be consistent with the quality data in the module 3. The course exactly show which annexes are quality related and makes them easier to remember. In this part of the course, the trainee will learn where to find relevant sections of module 3 containing information that are combined with annexes.
At the end, all current guidelines necessary for the correct preparation of individual sections of the module 3.2.P are listed. About 80 items of guidelines, questions and answers, reflection papers and websites are listed section by section. In addition, Ph.Eur. Medicinal Product Monographies are discussed from the point of view of impurities and dissolution, as well as time of monography implementation in relation to the marketing authorization of medicinal product. As a result, this training allows you to significantly save time in searching for the necessary reference documents, accelerate learning and reduce the risk of omitting important issues in the documentation.
