This course is created to introduce the idea of electronic submission of documentation and electronic Application Form 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 limited experience in area of registration processes of the medicinal products.
Student will learn what is an eSubmission Roadmap and eSubmission website, why were they created and how useful tools these are not only for Regulatory Affairs Team but also for whole pharmaceutical industry.
Student will see what is the scope of 5 eSubmission Roadmap Annexes that cover implementation of milestones.
In the course also the history of submission developing will be presented to better understand the way that the concept of electronic submission is evolving.
During the course Student will get elementary information also about the Common Electronic Submission Platform and where to find a basic information of this tool. It will be explained why it so popular and few advantages of this platform will be presented.
In addition, during the course an eSubmission Gateway will be discussed and it will be explained when can we use it for application submissions.
And the next subject covered by this course concern elementary information about electronic application form. Student will see where to find it, why it is better than paper version and also what is the expected future for this main registration application document.
As Regulatory Affairs Department members we are responsible for registration, variation, renewal and many other submissions for medicinal products. Our knowledge in this matter can support effective and undisturbed regulatory process. All information presented in this course will help a new employee to be better prepared to work with registration submissions and be prepared for upcoming changes in the scope of electronic submissions.
