CTD: case studies

  • Cours (CM) 8h
  • Cours intégrés (CI) -
  • Travaux dirigés (TD) 16h
  • Travaux pratiques (TP) -
  • Travail étudiant (TE) -

Langue de l'enseignement : Anglais

Description du contenu de l'enseignement

Personal work on:
- The study of monographs of the European Pharmacopoeia: group of two-three students will study a monograph resulting from the European Pharmacopoeia that will be allotted to them. The work will consist of exposing the contents of the monograph, describing the method, its usefulness, indicating its advantages and limitations. In addition, students will be asked to find alternative methods (in other references: food, environment, building, materials) whose performances they will compare with a critical eye. An assessment of the overall costs of implementing the method described in this monograph will be requested.
- Practical study of a Drug Marketing Authorization Application according to the CTD format. Groups of four to five students will have to write a Marketing Authorization Application for a Medicinal Product Specialty that will have been attributed to them. They will use all the lessons and knowledge learned during the two years of the Master studies. Group work will enable members to share their specific skills with others. They will have access to the latest European Pharmacopoeia, other available pharmacopoeias and all the bibliographic resources of the Common Documentation Service of the University of Strasbourg. They will benefit from the supervision of a tutor who will guide them across the work.

Compétences à acquérir

1) Ability to research, use and critically interpret the information contained in the European Pharmacopoeia
2) To participate in the drafting of a technical Drug Marketing Authorization Application by implementing the knowledge acquired during theoretical courses
3) To be able to research, synthesize and present scientific information in technical English.

Pré-requis obligatoires

Knowledge of theoretical courses and more particularly those concerning the production, the characterization and the pharmaceutical development of medicinal product.

Knowledge of technical English

Pré-requis recommandés

Knowledge of theoretical courses and more particularly those concerning the production, the characterization and the pharmaceutical development of medicinal product.

Knowledge of technical English

Contact

Faculté de Pharmacie

74 ROUTE DU RHIN
67401 ILLKIRCH-GRAFFENSTADEN
0368854110

Responsable

Marcella De Giorgi


MASTER - Biotechnologies

Plaquette Master Biotechnologies