This course provides an overview over the concepts and processes employed in today's drug discovery and development. It has an introductory character but will also provide more detailed insights employing real life examples. The course combines lectures and interactive elements with active participation of the students.
Learning objective
Students - Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes). - Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria. - Understand the concepts underlying drug product development through all the phases from preclinical and clinical development to regulatory submission, approval and market launch. - Can differentiate between small molecule drug development and biological drug development. - Understand the most important differences between legal and regulatory requirements for drug development and approval for the major markets EU and USA.
Content
Course unit comprises weekly lectures covering the early phases of target and drug discovery (535-0901-01 S "From A to Z in Drug Discovery and Development I") with group work in the area of Drug Development (511-0000-00 G). Group work is 2 full days (Days 1 and 2) and comprises: introduction to the entire suite of drug product development processes in the pharmaceutical industry, covering: preclinical research and development, clinical development, regulatory processes and market launch. R&D support processes such as project management, quality management, pharmacovigilance and pharmacoeconomics will be covered as well as organizational and governance aspects of the pharmaceutical industry. In addition, important success factors for a later career in the pharmaceutical industry will be discussed and highlighted at the end of the course.
Lecture notes
Will be published on "mystudies"
Literature
G. Nahler (Hrsg.) Dictionary of pharmaceutical medicine, Springer, Wien, 2013 (3rd edition) Further readings will be listed in the lecture notes.
Prerequisites / Notice
This course provides the essential basic knowledge required for the industry-specific modules of the spring semester.
Performance assessment as a semester course
: Special students and auditors need a special permission from the lecturers