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CORE TEACHING UNITS

COMPLEMENTARY TEACHING UNITS

DESCRIPTION OF THE TEACHING UNITS

Introductory Module, Principles of Drug Discovery

Introduction to the drug development process and the identification of essential factors and decision - making criteria.
Importance of patients and drug regulations in drug development.
Role of pathophysiology and molecular biology-based pharmacology, and the principles of translational medicine.
Introduction to the use of modelling in drug development.
Resource planning.

Non-Clinical Testing, Pharmaceutical and Preclinical Development

Outline of the non-clinical testing requirements prior to the first clinical trials in humans.
Choice and the predictive value of preclinical study programme in the overall drug development plan (including the scheduling of toxicology tests).
Principles and the application of pharmacokinetics and toxicokinetics.
Influence of genetic factors on drug development and therapeutic efficacy.

Exploratory and Confirmatory Clinical Development

First-in-patient trials (feasibility and dose-finding studies) and their consequences in terms of drug development.
Designing of clinical trials: legal, regulatory, ethical and practical aspects as well as the Good Clinical Practice guidelines.
Main operational and strategic issues while conducting clinical trials.

Clinical Trials

Different types of trial designs and the methods used to choose the appropriate plan.
Essentials of conducting clinical trials.
Quality management of clinical trials.
Main operational and strategic issues in terms of drug development.
Role of the various actors/committees involved in clinical trials.
Assessment and interpretation of clinical trial results (principal statistical methods and critical reading).

Regulatory Affairs, Drug Safety and Pharmacovigilance

General principles of drug regulation (pre- and post-marketing authorisation) at a European and global level.
Practical input of national agencies and international bodies in drug regulation.
National measures related to the unlicensed drug use (1) and controlled drug (2) management.
Role the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in drug regulation, including the Common Technical Document (CTD).

Healthcare Marketplace; Economics of Healthcare

Life-cycle management planning (clinical area, regulation, commercialisation and Good Promotional Practices).
Principles and implementation of healthcare economics and patient-reported outcomes in the pharmaceutical industry.
Principles of Health Technology Assessment (HTA) and its role in supplying the pharmaceutical market.
Drug budget monitoring and price determination mechanisms.

Project Management

Tutoring project in groups of 2-4 students supervised by a university lecturer and researcher.
Two weeks of management teaching given by the Lyon School Management.
Writing of a case study.
All groups are given the possibility of submitting an abstract and a poster to the French Society of Pharmacology and Therapeutics (SFPT).
All students can participate to the creation of a poster for the IPIL Industrial Day.
Introduction class to bibliographic research, including using Zotero.

EXAM REQUIREMENTS

An oral exam to evaluate the intensive English sessions in March.
A written exam, in the form of multiple choice questions on the six core teaching units and including a critical appraisal of an article, in March with a second session to resit in September, if necessary.
An oral exam in March to assess the tutoring project.
Writing of a case study in June.
A continuous assessment performed during the classes given by the EM Lyon.
Writing of an internship or apprenticeship report followed by an oral presentation in September.
Students must pass the TOIEC exam.