1. 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.
2. 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 2), How to choose the dose for first in human administration (module 5), Study designs (module 6) …
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 5-6,9 and 10 on clinical research.
4. 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 5,6,9 and 10 on clinical research.
5. 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 12.
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 14,15 and 16.
7. 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.
8. 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.
9. 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 to the PharmaTrain web site : https://www.pharmatrain.eu/e-library.php