This course is created to introduce the Structure and content of Module 4 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 4, and what is a correct structure and content of this Module.

In the course it will be explained if Module 4 is a part of the generic application or new product application.

It will be also explained when in the drug development process the Module 4 is created and what is a purpose of non-clinical documentation.

Student will learn why Module 4 is very important to the efficacy and safety of medicinal products and how the outcome of this part of testing determines the rest of the trials.

This knowledge helps to understand the content and the role of Module 4 in the dossier.

During the course Student will get basic information about the pharmacology (pharmacodynamics), pharmacokinetics and toxicology. In particular about ADME process.

Course explains how documentation in Module 4 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.