This course is created to introduce the Structure and content of Module 5 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 5, and what is a correct structure and content of this Module.

In the course it will be explained if Module 5 is a part only of the full dossier application or maybe it should be used also for generic product applications.

It will be also explained when in the drug development process the Module 5 is created and what is a purpose of clinical studies and clinical documentation.

Student will learn why Module 5 is very important to an efficacy and safety of medicinal products, how many phases have the clinical trials and what is their specification and if clinical trials end after medicinal product registration. This knowledge helps to understand the content and the role of Module 5 in the dossier.

During the course Student will get information about the requirements for listing of clinical studies and learn basic notice about Bioavailability and Bioequivalence studies. In addition it will be presented what are the Human Biomaterials and when are they used.

Course explains how documentation in Module 5 is linked with the rest of the Modules and what is a difference between Overview and Summary files.

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.