E Library
Nine e learning modules covering several aspects of the medicines development process have
been created in the framework of the IMI (Innovative Medicines Initiative) project
PharmaTrain. They were produced by Hibernia College, HSeT and ScienceMedia, with the
support of UCB, Novartis, Amgen, Astra Zeneca, Pfizer and PHARMED. These short
modules can be used as a preparation before face-to-face sessions, or as post-session
complementary reading. Several of these modules will provide an introduction to different
topics, allowing greater interactivity and focus on real life cases during the face-to-face
courses.
 Introduction to drug development
This lesson presents an helicopter view of the drug development process covering : context of
drug development, drug discovery and preclinical development, ethics and Good Clinical
Practice, clinical research, regulatory affairs, pharmacovigilance and health economics. It is
highly recommended to visit this module before joining the PHARMED course.
 How to get it right – The scientific basis of formulating dose-response
Selecting the right dose is one of the most difficult steps in drug development. Both efficacy
and safety are concerned, and variability is a major issue. This module is directly related to
various PHARMED courses : Ligand receptor interactions (module 1), How to choose the
dose for first in human administration (module 2), Study designs (module 3) …
 Introduction to ethical issues in clinical research
The purpose of this lesson is to sensitise participants to ethical issues in clinical research.
Visiting this module is highly recommended before attendance of modules 3-5 on clinical
research.
 Introduction to Good Clinical practice
This module reminds the historical events that led to the current regulations of clinical
research and provides an overview of ICH-GCP. Visiting this module is highly recommended
before attendance of modules 3-5 on clinical research.
 Introduction to the registration of medicinal products
This lesson presents an overview of the regulation of medicines and of the process of
medicinal products registration, with an emphasis on the European regulatory environment.
This module should be visited before the attendance of module 6.
 Introduction to health economics
This module provides an overview of health economics. It presents the various economic
evaluations, describes the various costs and measures of effectiveness and utility, and
discusses in greater details the concept of cost-effectiveness analysis. It should be visited
before attendance of modules 7 and 8.
 Full development of a monoclonal antibody
This lesson describes key events in the evolution of biotechnology, discusses the use of
various mAb for immunotherapy and presents an overview of the full development of one
mAb from target identification to the market : denosumab for the treatment of osteoporosis.
This module will be of great value for those who cannot attend the course Overview of the
development of a medicinal product : the story of denosumab, in module 1.
 Parkinson’s disease
This module describes Parkinson’s disease as a prototype of neurodegenerative disorder. It
covers pathophysiology, diagnosis, epidemiology, current and future treatments and
guidelines for the development of new treatments in that particular therapeutic area. This
module will be particularly useful for those who have not a medical background.
 Asthma and COPD
After a reminder of respiratory physiology, this lesson describes the basic principles of
treatment and provides an access to various guidelines on treatment and development of new
medicinal products in this important therapeutic area. This module will be particularly useful
for those who have not a medical background.
To access those modules go the PharmaTrain web site and register for free, or simply click on
their title on this page.