Discover detailed program for 6 modules!
1- Setting the scene : the context of drug development
2- Integrated product development : from discovery phase to market authorization
3- Drug screening : from animals to recombinant proteins and translational research
4- Big data and personnalized medicine : How AI can potentially reinvent the drug design and development ?
At the end of this module, the student should be able to outline the :
1- Principal steps in drug development
2- Specificities of the current changing heath care environment
3- Principal steps and innovations in drug screening
4- Principles of translational research and personnalized medecine
5- Would-be contribution of Artificial Intelligence in drug design and development
1- Pre-clinical strategy and Study design
2- Pre-clinical safety : Principles of pharmacology and toxicology
3- Drug formulation
4- Manufacturing
5- Moving to First-in-Human studies
At the end of this module, the student should be able to outline the :
1- Principles of pre-clinical strategy
2- Requirements, ethics and regulation of pre-clinical and First-in-Human studies
3- Basic concepts of pre-clinical pharmacology and toxicology
4- Main aspects of drug formulation and innovations in this area
5- Pharmaceutical technical development
6- Requirements and regulations in drug manufacturing
7- Planning and practical organization of Phase I studies
1- Early studies in patients
2- Clinical trials Designs
3- Planning and managing clinical trials
4- Collecting clinical trials data
5- Blockchain in Clinical trials
At the end of this module, the student should be able to outline the :
1- Main aspects of early studies in patients and their impact on the drug development plan
2- Design of various types of clinical studies ans statistical aspects of these designs
3- Key issues involved in a conduct of a clinical study in terms of Good Clinical Practice (GCP)
4- Main safety aspects in clinical trials and drug development
5- Principles and tools of data collection
6- Key steps and methods in data management
7- Applications of Blockchain in clinical trials
1- Clinical trial protocol and Investigator drug brochure (IDB)
2- Biostatistics : Clinical data Evaluation
3- Safety data Evaluation
4- Data Interpretation and Scientific writing
At the end of this module, the student should be able to outline the :
1- Development of a clinical trial protocol and the role of the Investigator Drug Brochure (IDB)
2- Evaluation and interpretation of clinical trial results in a scientific publication
3- Main statistical methods used in clinical data analysis and understand the current challenges aroud the p-value
4- Main aspects of the Clinical Study Report and the documents for regulatory submission
1- Drug Registration : European procedures and International environment
2- Pharmacovigilance & Medical information
3- Pharmacoepidemiology
At the end of this module, the student should be able to outline the :
1- General principles of medicinesregulation (pre- and post- approval)
2- Principles of pharmacovigilance and medical information
3- Role of Pharmacoepidemiology in the lifecycle of a medecine
1- Principles and practical applications of health economics
2- Market access
3- Innovation and improvement of health care
At the end of this module, the student should be able to outline the :
1- Principles and practical applications of health economics and Health Technology Assessment within the healthcare marketplace
2- Ethical and legal aspects of market introduction of a drug
3- Specificities of a really innovative product
Biologics, Vaccines, ATMPs, Medical advices : how do they differ from conventional drugs ?