This course is created to introduce the Structure and content of Module 2 of the medicinal product’s dossier to the new employee of the Regulatory Affairs Department. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company and have none or very limited experience in registration documentation of the medicinal products.

Student will learn what kind of guidelines are available for the preparation of Module number 2, and what is correct structure and content of this Module.

By attending this course, student will learn about definition of Common Technical Document (CTD) and basic information about full dossier structure. This knowledge helps to understand the content and the role of Module 2 in the dossier.

During the course Student will get information about table of contents, introduction, quality, non-clinical and clinical part of the Module 2 and will learn who prepares documents that are required in this section.

Course explains contrasts between Overview and Summary files that are presented in this part of the dossier and have crucial role during the registration or variation application assessment.

In addition course includes information about appropriate lengths of the documents and the possible differences in the content of Module number 2 based on the type of application.

As Regulatory Affairs Department members we have impact on the quality of submitted files and our knowledge can support effective and undisturbed regulatory process. All information presented in this course will help a new employee to be better prepared to check and validate the dossier before registration or variation application submission.