Upon completion of this course, students will be able to 
demonstrate:
1. An understanding of the European Regulatory structure and
agencies involved with filing a new medicinal product 
application.
2. An understanding of the significance of the organizational
structure of European Commission and Notified Bodies.
3. An understanding of the different approaches in regulating
different types of medicinal products, including Council
Regulations and Directives.
4. An understanding of the differences between pre-market
approval decision making and post-market compliance decision 
making.
5. An understanding of international pharmacovigilance.
6. To develop a basic understanding of the Quality Systems and
Inspection Processes for Pharmaceutical Companies.
7. To develop the ability to think critically about how
regulatory agencies help protect the health and safety of 
people around the world.
8. What it takes to grant a Medicinal Product and Marketing
Authorisation in Europe.
9. To understand the legal obligations of the Marketing
Authorisation holder; what the different options are and how to 
maintain a dossier life cycle.

Topic
Mod 0 – Introduction and history of EM(E)A and glossary of 200
definitions
Mod 1 – Regulatory strategy and pre-submission – Intro and
definitions – Part A
Mod 2 – Regulatory strategy and pre-submission – Intro and
definitions – Part B
Mod 3 – Regulatory strategy and pre-submission – Possible 
options and support
Mod 4 – Regulatory strategy and pre-submission – Patent, data
exclusivity, and data protection
Mod 5 – Regulatory strategy and pre-submission – Standard drug
development process
Mod 6 – Regulatory strategy and pre-submission – The art of 
writing a regulatory submission dossier
Mod 7 – Dossier preparation and submission – Part A
Mod 8 – Dossier preparation and submission – Part B
Mod 9 – Approval process – Centralized procedure  
Mod 10 – Approval process – MRP procedure  
Mod 11 – Approval process – DCP and national procedure  
Mod 12 – Approval process – Implementation and license
Mod 13 – Post approval commitments and responsibilities
Mod 14 – Life Cycle management – Part A
Mod 15 – Life Cycle management – Part B

All academic work must meet the standards contained in A 
Culture of Honesty.  Each student is responsible to inform 
themselves about those standards before performing any 
academic work.  A Culture of Honesty is the University of 
Georgia’s policy and procedures for handling cases of 
suspected dishonesty and can be found online at 
www.uga.edu/honesty.  The UGA Student Honor Code states “I 
will be academically honest in all of my academic work and 
will not tolerate academic dishonesty of others.”