Basics of Regulatory Affairs-February

The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background.

The purpose of this Basics course is to provide you with a clear and concise understanding of the role played by Regulatory Affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical products. This is a one-day foundation course for very new recruits, PAs, administrators and support staff in Regulatory Affairs and other related areas such as Medical, Manufacturing, Marketing etc. Suitable for staff in agencies and companies.

Who should attend

● Those new to regulatory affairs or those wishing to move into the profession
● Experienced staff from related disciplines, e.g. manufacturing, marketing and sales
● Support staff
● Anyone requiring an overview of regulatory affairs

What previous delegates have had to say about this course…
“ Speakers very clear, concise and informative”
“ Excellent overview in such a short time!”
“ Made things a lot clearer and gave me an understanding of how things link together.”
“ Well structured set of presentations and very informative.”

What you will learn
● Background to regulatory affairs
● The European legislative framework
● Overview of drug development
● Overview of clinical trails
● Marketing Authorisation Applications
● Labels and leaflets
● European Procedures
● Lifecycle management, including variations

And there will be quizzes and prizes too! This course will give a basic grounding in a relaxed, enjoyable environment.

The online booking form is for the next available course, which is in February. However, we also run the same course in April, June (Ireland), August, October and November.

If you prefer to book for any of those course, click on the relevant links below:

April
June (Ireland)
August
October
November

Registration: 09.30-10.00
Start of course: 10.00
End of course: 16.00