European Pharmaceutical and Biologics Regulatory Sciences
PHAR 6340E
3 hours
European Pharmaceutical and Biologics Regulatory Sciences
Course Description
An in-depth examination of the European Biomedical Regulatory
landscape for obtaining marketing approval for drugs and
biologics in the European Union, including early medical product
development, clinical trial phases, marketing, and
pharmacovigilance.
Athena Title
EU Biomedical Regulatory Scien
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
Students will describe the European regulatory structure and agencies involved in filing a new medicinal product application.
Students will explain the significance of the organizational structure of the European Commission and Notified Bodies.
Students will differentiate among the regulatory approaches used for different types of medicinal products, including Council Regulations and Directives.
Students will compare and contrast pre-market approval decision making and post-market compliance decision making.
Students will describe the principles and practices of international pharmacovigilance.
Students will describe the quality systems and inspection processes for pharmaceutical companies.
Students will analyze how regulatory agencies help protect the health and safety of people around the world.
Students will describe the requirements and processes for obtaining a Medicinal Product Marketing Authorisation in Europe.
Students will explain the legal obligations of a Marketing Authorisation Holder (MAH), identify available regulatory options, and describe the maintenance of a dossier throughout its lifecycle.
Topical Outline
Introduction and history of EM(E)A and glossary of 200 definitions
Regulatory strategy and pre-submission – Intro and definitions – Part A
Regulatory strategy and pre-submission – Intro and definitions – Part B
Regulatory strategy and pre-submission – Possible options and support
Regulatory strategy and pre-submission – Patent, data exclusivity, and data protection
Regulatory strategy and pre-submission – Standard drug development process
Regulatory strategy and pre-submission – The art of writing a regulatory submission dossier
